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id="toc-Trials_of_drugs" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Trials_of_drugs"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.1</span> <span>Trials of drugs</span> </div> </a> <ul id="toc-Trials_of_drugs-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Trials_of_devices" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Trials_of_devices"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.2</span> <span>Trials of devices</span> </div> </a> <ul id="toc-Trials_of_devices-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Trials_of_procedures" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Trials_of_procedures"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.3</span> <span>Trials of procedures</span> </div> </a> <ul id="toc-Trials_of_procedures-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Patient_and_public_involvement" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Patient_and_public_involvement"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.4</span> <span>Patient and public involvement</span> </div> </a> <ul id="toc-Patient_and_public_involvement-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-History" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#History"> <div class="vector-toc-text"> <span class="vector-toc-numb">2</span> <span>History</span> </div> </a> <button aria-controls="toc-History-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle History subsection</span> </button> <ul id="toc-History-sublist" class="vector-toc-list"> <li id="toc-Development" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Development"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.1</span> <span>Development</span> </div> </a> <ul id="toc-Development-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Modern_trials" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Modern_trials"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.2</span> <span>Modern trials</span> </div> </a> <ul id="toc-Modern_trials-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Types" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Types"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>Types</span> </div> </a> <button aria-controls="toc-Types-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Types subsection</span> </button> <ul id="toc-Types-sublist" class="vector-toc-list"> <li id="toc-Phases" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Phases"> <div class="vector-toc-text"> <span class="vector-toc-numb">3.1</span> <span>Phases</span> </div> </a> <ul id="toc-Phases-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Trial_design" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Trial_design"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Trial design</span> </div> </a> <button aria-controls="toc-Trial_design-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Trial design subsection</span> </button> <ul id="toc-Trial_design-sublist" class="vector-toc-list"> <li id="toc-Active_control_studies" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Active_control_studies"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.1</span> <span>Active control studies</span> </div> </a> <ul id="toc-Active_control_studies-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Master_protocol" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Master_protocol"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.2</span> <span>Master protocol</span> </div> </a> <ul id="toc-Master_protocol-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Clinical_trial_protocol" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Clinical_trial_protocol"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.3</span> <span>Clinical trial protocol</span> </div> </a> <ul id="toc-Clinical_trial_protocol-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Design_features" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Design_features"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.4</span> <span>Design features</span> </div> </a> <ul id="toc-Design_features-sublist" class="vector-toc-list"> <li id="toc-Informed_consent" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Informed_consent"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.4.1</span> <span>Informed consent</span> </div> </a> <ul id="toc-Informed_consent-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Statistical_power" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Statistical_power"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.4.2</span> <span>Statistical power</span> </div> </a> <ul id="toc-Statistical_power-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Placebo_groups" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Placebo_groups"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5</span> <span>Placebo groups</span> </div> </a> <ul id="toc-Placebo_groups-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Duration" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Duration"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.6</span> <span>Duration</span> </div> </a> <ul id="toc-Duration-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Administration" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Administration"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>Administration</span> </div> </a> <button aria-controls="toc-Administration-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Administration subsection</span> </button> <ul id="toc-Administration-sublist" class="vector-toc-list"> <li id="toc-Quality" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Quality"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.1</span> <span>Quality</span> </div> </a> <ul id="toc-Quality-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Marketing" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Marketing"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.2</span> <span>Marketing</span> </div> </a> <ul id="toc-Marketing-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Information_technology" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Information_technology"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.3</span> <span>Information technology</span> </div> </a> <ul id="toc-Information_technology-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Analysis" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Analysis"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Analysis</span> </div> </a> <ul id="toc-Analysis-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Ethical_aspects" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Ethical_aspects"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>Ethical aspects</span> </div> </a> <button aria-controls="toc-Ethical_aspects-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Ethical aspects subsection</span> </button> <ul id="toc-Ethical_aspects-sublist" class="vector-toc-list"> <li id="toc-Conflicts_of_interest_and_unfavorable_studies" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Conflicts_of_interest_and_unfavorable_studies"> <div class="vector-toc-text"> <span class="vector-toc-numb">7.1</span> <span>Conflicts of interest and unfavorable studies</span> </div> </a> <ul id="toc-Conflicts_of_interest_and_unfavorable_studies-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-During_public_health_crisis" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#During_public_health_crisis"> <div class="vector-toc-text"> <span class="vector-toc-numb">7.2</span> <span>During public health crisis</span> </div> </a> <ul id="toc-During_public_health_crisis-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Pregnant_women_and_children" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Pregnant_women_and_children"> <div class="vector-toc-text"> <span class="vector-toc-numb">7.3</span> <span>Pregnant women and children</span> </div> </a> <ul id="toc-Pregnant_women_and_children-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Safety" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Safety"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>Safety</span> </div> </a> <button aria-controls="toc-Safety-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Safety subsection</span> </button> <ul id="toc-Safety-sublist" class="vector-toc-list"> <li id="toc-Sponsor" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Sponsor"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.1</span> <span>Sponsor</span> </div> </a> <ul id="toc-Sponsor-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Local_site_investigators" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Local_site_investigators"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.2</span> <span>Local site investigators</span> </div> </a> <ul id="toc-Local_site_investigators-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Institutional_review_boards_(IRBs)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Institutional_review_boards_(IRBs)"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.3</span> <span>Institutional review boards (IRBs)</span> </div> </a> <ul id="toc-Institutional_review_boards_(IRBs)-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Regulatory_agencies" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Regulatory_agencies"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.4</span> <span>Regulatory agencies</span> </div> </a> <ul id="toc-Regulatory_agencies-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Aggregation_of_safety_data_during_clinical_development" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Aggregation_of_safety_data_during_clinical_development"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.5</span> <span>Aggregation of safety data during clinical development</span> </div> </a> <ul id="toc-Aggregation_of_safety_data_during_clinical_development-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Economics" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Economics"> <div class="vector-toc-text"> <span class="vector-toc-numb">9</span> <span>Economics</span> </div> </a> <button aria-controls="toc-Economics-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Economics subsection</span> </button> <ul id="toc-Economics-sublist" class="vector-toc-list"> <li id="toc-Sponsor_2" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Sponsor_2"> <div class="vector-toc-text"> <span class="vector-toc-numb">9.1</span> <span>Sponsor</span> </div> </a> <ul id="toc-Sponsor_2-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Investigators" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Investigators"> <div class="vector-toc-text"> <span class="vector-toc-numb">9.2</span> <span>Investigators</span> </div> </a> <ul id="toc-Investigators-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Subjects" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Subjects"> <div class="vector-toc-text"> <span class="vector-toc-numb">9.3</span> <span>Subjects</span> </div> </a> <ul id="toc-Subjects-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Participant_recruitment_and_participation" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Participant_recruitment_and_participation"> <div class="vector-toc-text"> <span class="vector-toc-numb">10</span> <span>Participant recruitment and participation</span> </div> </a> <button aria-controls="toc-Participant_recruitment_and_participation-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Participant recruitment and participation subsection</span> </button> <ul id="toc-Participant_recruitment_and_participation-sublist" class="vector-toc-list"> <li id="toc-Locating_trials" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Locating_trials"> <div class="vector-toc-text"> <span class="vector-toc-numb">10.1</span> <span>Locating trials</span> </div> </a> <ul id="toc-Locating_trials-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Research"> <div class="vector-toc-text"> <span class="vector-toc-numb">10.2</span> <span>Research</span> </div> </a> <ul id="toc-Research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Matching" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Matching"> <div class="vector-toc-text"> <span class="vector-toc-numb">10.3</span> <span>Matching</span> </div> </a> <ul id="toc-Matching-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Decentralized_trials" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Decentralized_trials"> <div class="vector-toc-text"> <span class="vector-toc-numb">11</span> <span>Decentralized trials</span> </div> </a> <ul id="toc-Decentralized_trials-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">12</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">13</span> <span>References</span> </div> </a> <ul id="toc-References-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-External_links" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#External_links"> <div class="vector-toc-text"> <span class="vector-toc-numb">14</span> <span>External links</span> </div> </a> <ul id="toc-External_links-sublist" class="vector-toc-list"> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div id="vector-page-titlebar-toc" class="vector-dropdown vector-page-titlebar-toc vector-button-flush-left" > <input type="checkbox" id="vector-page-titlebar-toc-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-titlebar-toc" class="vector-dropdown-checkbox " aria-label="Toggle the table of contents" > <label id="vector-page-titlebar-toc-label" for="vector-page-titlebar-toc-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-listBullet mw-ui-icon-wikimedia-listBullet"></span> <span class="vector-dropdown-label-text">Toggle the table of contents</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-titlebar-toc-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <h1 id="firstHeading" class="firstHeading mw-first-heading"><span class="mw-page-title-main">Clinical trial</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Go to an article in another language. Available in 42 languages" > <label id="p-lang-btn-label" for="p-lang-btn-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--action-progressive mw-portlet-lang-heading-42" aria-hidden="true" ><span class="vector-icon mw-ui-icon-language-progressive mw-ui-icon-wikimedia-language-progressive"></span> <span class="vector-dropdown-label-text">42 languages</span> </label> <div class="vector-dropdown-content"> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li class="interlanguage-link interwiki-ar mw-list-item"><a href="https://ar.wikipedia.org/wiki/%D8%AA%D8%AC%D8%B1%D8%A8%D8%A9_%D8%B3%D8%B1%D9%8A%D8%B1%D9%8A%D8%A9" title="تجربة سريرية – Arabic" lang="ar" hreflang="ar" data-title="تجربة سريرية" data-language-autonym="العربية" data-language-local-name="Arabic" class="interlanguage-link-target"><span>العربية</span></a></li><li class="interlanguage-link interwiki-ast mw-list-item"><a href="https://ast.wikipedia.org/wiki/Ensayu_cl%C3%ADnicu" title="Ensayu clínicu – Asturian" lang="ast" hreflang="ast" data-title="Ensayu clínicu" data-language-autonym="Asturianu" data-language-local-name="Asturian" class="interlanguage-link-target"><span>Asturianu</span></a></li><li class="interlanguage-link interwiki-bn mw-list-item"><a href="https://bn.wikipedia.org/wiki/%E0%A6%B0%E0%A7%8B%E0%A6%97%E0%A7%80%E0%A6%AD%E0%A6%BF%E0%A6%A4%E0%A7%8D%E0%A6%A4%E0%A6%BF%E0%A6%95_%E0%A6%AA%E0%A6%B0%E0%A7%80%E0%A6%95%E0%A7%8D%E0%A6%B7%E0%A6%A3" title="রোগীভিত্তিক পরীক্ষণ – Bangla" lang="bn" hreflang="bn" data-title="রোগীভিত্তিক পরীক্ষণ" data-language-autonym="বাংলা" data-language-local-name="Bangla" class="interlanguage-link-target"><span>বাংলা</span></a></li><li class="interlanguage-link interwiki-bg mw-list-item"><a href="https://bg.wikipedia.org/wiki/%D0%9A%D0%BB%D0%B8%D0%BD%D0%B8%D1%87%D0%BD%D0%BE_%D0%B8%D0%B7%D0%BF%D0%B8%D1%82%D0%B2%D0%B0%D0%BD%D0%B5" title="Клинично изпитване – Bulgarian" lang="bg" hreflang="bg" data-title="Клинично изпитване" data-language-autonym="Български" data-language-local-name="Bulgarian" class="interlanguage-link-target"><span>Български</span></a></li><li class="interlanguage-link interwiki-ca mw-list-item"><a href="https://ca.wikipedia.org/wiki/Assaig_cl%C3%ADnic" title="Assaig clínic – Catalan" lang="ca" hreflang="ca" data-title="Assaig clínic" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-cs mw-list-item"><a href="https://cs.wikipedia.org/wiki/Klinick%C3%A1_studie" title="Klinická studie – Czech" lang="cs" hreflang="cs" data-title="Klinická studie" data-language-autonym="Čeština" data-language-local-name="Czech" class="interlanguage-link-target"><span>Čeština</span></a></li><li class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/Klinisk_unders%C3%B8gelse" title="Klinisk undersøgelse – Danish" lang="da" hreflang="da" data-title="Klinisk undersøgelse" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/Klinische_Studie" title="Klinische Studie – German" lang="de" hreflang="de" data-title="Klinische Studie" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Ensayo_cl%C3%ADnico" title="Ensayo clínico – Spanish" lang="es" hreflang="es" data-title="Ensayo clínico" data-language-autonym="Español" data-language-local-name="Spanish" class="interlanguage-link-target"><span>Español</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%DA%A9%D8%A7%D8%B1%D8%A2%D8%B2%D9%85%D8%A7%DB%8C%DB%8C_%D8%A8%D8%A7%D9%84%DB%8C%D9%86%DB%8C" title="کارآزمایی بالینی – Persian" lang="fa" hreflang="fa" data-title="کارآزمایی بالینی" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Essai_clinique" title="Essai clinique – French" lang="fr" hreflang="fr" data-title="Essai clinique" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-gl mw-list-item"><a href="https://gl.wikipedia.org/wiki/Ensaio_cl%C3%ADnico" title="Ensaio clínico – Galician" lang="gl" hreflang="gl" data-title="Ensaio clínico" data-language-autonym="Galego" data-language-local-name="Galician" class="interlanguage-link-target"><span>Galego</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98" title="임상시험 – Korean" lang="ko" hreflang="ko" data-title="임상시험" data-language-autonym="한국어" data-language-local-name="Korean" class="interlanguage-link-target"><span>한국어</span></a></li><li class="interlanguage-link interwiki-hi mw-list-item"><a href="https://hi.wikipedia.org/wiki/%E0%A4%A8%E0%A5%88%E0%A4%A6%E0%A4%BE%E0%A4%A8%E0%A4%BF%E0%A4%95_%E0%A4%AA%E0%A4%B0%E0%A5%80%E0%A4%95%E0%A5%8D%E0%A4%B7%E0%A4%A3" title="नैदानिक परीक्षण – Hindi" lang="hi" hreflang="hi" data-title="नैदानिक परीक्षण" data-language-autonym="हिन्दी" data-language-local-name="Hindi" class="interlanguage-link-target"><span>हिन्दी</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Uji_klinis" title="Uji klinis – Indonesian" lang="id" hreflang="id" data-title="Uji klinis" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-it mw-list-item"><a href="https://it.wikipedia.org/wiki/Studio_clinico" title="Studio clinico – Italian" lang="it" hreflang="it" data-title="Studio clinico" data-language-autonym="Italiano" data-language-local-name="Italian" class="interlanguage-link-target"><span>Italiano</span></a></li><li class="interlanguage-link interwiki-he mw-list-item"><a href="https://he.wikipedia.org/wiki/%D7%A0%D7%99%D7%A1%D7%95%D7%99_%D7%A7%D7%9C%D7%99%D7%A0%D7%99" title="ניסוי קליני – Hebrew" lang="he" hreflang="he" data-title="ניסוי קליני" data-language-autonym="עברית" data-language-local-name="Hebrew" class="interlanguage-link-target"><span>עברית</span></a></li><li class="interlanguage-link interwiki-lt mw-list-item"><a href="https://lt.wikipedia.org/wiki/Klinikinis_tyrimas" title="Klinikinis tyrimas – Lithuanian" lang="lt" hreflang="lt" data-title="Klinikinis tyrimas" data-language-autonym="Lietuvių" data-language-local-name="Lithuanian" class="interlanguage-link-target"><span>Lietuvių</span></a></li><li class="interlanguage-link interwiki-mk mw-list-item"><a href="https://mk.wikipedia.org/wiki/%D0%9A%D0%BB%D0%B8%D0%BD%D0%B8%D1%87%D0%BA%D0%BE_%D0%B8%D1%81%D0%BF%D0%B8%D1%82%D1%83%D0%B2%D0%B0%D1%9A%D0%B5" title="Клиничко испитување – Macedonian" lang="mk" hreflang="mk" data-title="Клиничко испитување" data-language-autonym="Македонски" data-language-local-name="Macedonian" class="interlanguage-link-target"><span>Македонски</span></a></li><li class="interlanguage-link interwiki-mr mw-list-item"><a href="https://mr.wikipedia.org/wiki/%E0%A4%9A%E0%A4%BF%E0%A4%95%E0%A4%BF%E0%A4%A4%E0%A5%8D%E0%A4%B8%E0%A4%BE%E0%A4%B6%E0%A4%BE%E0%A4%B8%E0%A5%8D%E0%A4%A4%E0%A5%8D%E0%A4%B0%E0%A5%80%E0%A4%AF_%E0%A4%B8%E0%A4%82%E0%A4%AA%E0%A4%B0%E0%A5%80%E0%A4%95%E0%A5%8D%E0%A4%B7%E0%A4%A3" title="चिकित्साशास्त्रीय संपरीक्षण – Marathi" lang="mr" hreflang="mr" data-title="चिकित्साशास्त्रीय संपरीक्षण" data-language-autonym="मराठी" data-language-local-name="Marathi" class="interlanguage-link-target"><span>मराठी</span></a></li><li class="interlanguage-link interwiki-ms mw-list-item"><a href="https://ms.wikipedia.org/wiki/Ujian_klinikal" title="Ujian klinikal – Malay" lang="ms" hreflang="ms" data-title="Ujian klinikal" data-language-autonym="Bahasa Melayu" data-language-local-name="Malay" class="interlanguage-link-target"><span>Bahasa Melayu</span></a></li><li class="interlanguage-link interwiki-nl mw-list-item"><a href="https://nl.wikipedia.org/wiki/Klinisch_onderzoek" title="Klinisch onderzoek – Dutch" lang="nl" hreflang="nl" data-title="Klinisch onderzoek" data-language-autonym="Nederlands" data-language-local-name="Dutch" class="interlanguage-link-target"><span>Nederlands</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E6%B2%BB%E9%A8%93" title="治験 – Japanese" lang="ja" hreflang="ja" data-title="治験" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-no mw-list-item"><a href="https://no.wikipedia.org/wiki/Kliniske_studier" title="Kliniske studier – Norwegian Bokmål" lang="nb" hreflang="nb" data-title="Kliniske studier" data-language-autonym="Norsk bokmål" data-language-local-name="Norwegian Bokmål" class="interlanguage-link-target"><span>Norsk bokmål</span></a></li><li class="interlanguage-link interwiki-pl mw-list-item"><a href="https://pl.wikipedia.org/wiki/Eksperyment_kliniczny" title="Eksperyment kliniczny – Polish" lang="pl" hreflang="pl" data-title="Eksperyment kliniczny" data-language-autonym="Polski" data-language-local-name="Polish" class="interlanguage-link-target"><span>Polski</span></a></li><li class="interlanguage-link interwiki-pt mw-list-item"><a href="https://pt.wikipedia.org/wiki/Ensaio_cl%C3%ADnico" title="Ensaio clínico – Portuguese" lang="pt" hreflang="pt" data-title="Ensaio clínico" data-language-autonym="Português" data-language-local-name="Portuguese" class="interlanguage-link-target"><span>Português</span></a></li><li class="interlanguage-link interwiki-ro mw-list-item"><a href="https://ro.wikipedia.org/wiki/Studiu_clinic" title="Studiu clinic – Romanian" lang="ro" hreflang="ro" data-title="Studiu clinic" data-language-autonym="Română" data-language-local-name="Romanian" class="interlanguage-link-target"><span>Română</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/%D0%9A%D0%BB%D0%B8%D0%BD%D0%B8%D1%87%D0%B5%D1%81%D0%BA%D0%BE%D0%B5_%D0%B8%D1%81%D1%81%D0%BB%D0%B5%D0%B4%D0%BE%D0%B2%D0%B0%D0%BD%D0%B8%D0%B5" title="Клиническое исследование – Russian" lang="ru" hreflang="ru" data-title="Клиническое исследование" data-language-autonym="Русский" data-language-local-name="Russian" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-si mw-list-item"><a href="https://si.wikipedia.org/wiki/%E0%B7%83%E0%B7%8F%E0%B6%BA%E0%B6%B1%E0%B7%92%E0%B6%9A_%E0%B6%85%E0%B6%AD%E0%B7%8A%E0%B7%84%E0%B6%AF%E0%B7%8F_%E0%B6%B6%E0%B7%90%E0%B6%BD%E0%B7%93%E0%B6%B8" title="සායනික අත්හදා බැලීම – Sinhala" lang="si" hreflang="si" data-title="සායනික අත්හදා බැලීම" data-language-autonym="සිංහල" data-language-local-name="Sinhala" class="interlanguage-link-target"><span>සිංහල</span></a></li><li class="interlanguage-link interwiki-simple mw-list-item"><a href="https://simple.wikipedia.org/wiki/Clinical_trial" title="Clinical trial – Simple English" lang="en-simple" hreflang="en-simple" data-title="Clinical trial" data-language-autonym="Simple English" data-language-local-name="Simple English" class="interlanguage-link-target"><span>Simple English</span></a></li><li class="interlanguage-link interwiki-sl mw-list-item"><a href="https://sl.wikipedia.org/wiki/Klini%C4%8Dno_presku%C5%A1anje" title="Klinično preskušanje – Slovenian" lang="sl" hreflang="sl" data-title="Klinično preskušanje" data-language-autonym="Slovenščina" data-language-local-name="Slovenian" class="interlanguage-link-target"><span>Slovenščina</span></a></li><li class="interlanguage-link interwiki-sr mw-list-item"><a href="https://sr.wikipedia.org/wiki/Klini%C4%8Dko_ispitivanje" title="Kliničko ispitivanje – Serbian" lang="sr" hreflang="sr" data-title="Kliničko ispitivanje" data-language-autonym="Српски / srpski" data-language-local-name="Serbian" class="interlanguage-link-target"><span>Српски / srpski</span></a></li><li class="interlanguage-link interwiki-sh mw-list-item"><a href="https://sh.wikipedia.org/wiki/Klini%C4%8Dko_ispitivanje" title="Kliničko ispitivanje – Serbo-Croatian" lang="sh" hreflang="sh" data-title="Kliničko ispitivanje" data-language-autonym="Srpskohrvatski / српскохрватски" data-language-local-name="Serbo-Croatian" class="interlanguage-link-target"><span>Srpskohrvatski / српскохрватски</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/Kliininen_koe" title="Kliininen koe – Finnish" lang="fi" hreflang="fi" data-title="Kliininen koe" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-sv mw-list-item"><a href="https://sv.wikipedia.org/wiki/Klinisk_pr%C3%B6vning" title="Klinisk prövning – Swedish" lang="sv" hreflang="sv" data-title="Klinisk prövning" data-language-autonym="Svenska" data-language-local-name="Swedish" class="interlanguage-link-target"><span>Svenska</span></a></li><li class="interlanguage-link interwiki-ta mw-list-item"><a href="https://ta.wikipedia.org/wiki/%E0%AE%AE%E0%AE%B0%E0%AF%81%E0%AE%A8%E0%AF%8D%E0%AE%A4%E0%AE%BF%E0%AE%AF%E0%AE%95%E0%AF%8D%E0%AE%95%E0%AE%9A%E0%AF%8D_%E0%AE%9A%E0%AF%8B%E0%AE%A4%E0%AE%A9%E0%AF%88" title="மருந்தியக்கச் சோதனை – Tamil" lang="ta" hreflang="ta" data-title="மருந்தியக்கச் சோதனை" data-language-autonym="தமிழ்" data-language-local-name="Tamil" class="interlanguage-link-target"><span>தமிழ்</span></a></li><li class="interlanguage-link interwiki-th mw-list-item"><a href="https://th.wikipedia.org/wiki/%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%97%E0%B8%94%E0%B8%A5%E0%B8%AD%E0%B8%87%E0%B8%97%E0%B8%B2%E0%B8%87%E0%B8%84%E0%B8%A5%E0%B8%B4%E0%B8%99%E0%B8%B4%E0%B8%81" title="การทดลองทางคลินิก – Thai" lang="th" hreflang="th" data-title="การทดลองทางคลินิก" data-language-autonym="ไทย" data-language-local-name="Thai" class="interlanguage-link-target"><span>ไทย</span></a></li><li class="interlanguage-link interwiki-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/Klinik_%C3%A7al%C4%B1%C5%9Fma" title="Klinik çalışma – Turkish" lang="tr" hreflang="tr" data-title="Klinik çalışma" data-language-autonym="Türkçe" data-language-local-name="Turkish" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-uk mw-list-item"><a href="https://uk.wikipedia.org/wiki/%D0%9A%D0%BB%D1%96%D0%BD%D1%96%D1%87%D0%BD%D0%B5_%D0%B2%D0%B8%D0%BF%D1%80%D0%BE%D0%B1%D1%83%D0%B2%D0%B0%D0%BD%D0%BD%D1%8F" title="Клінічне випробування – Ukrainian" lang="uk" hreflang="uk" data-title="Клінічне випробування" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-vi mw-list-item"><a href="https://vi.wikipedia.org/wiki/Th%E1%BB%AD_nghi%E1%BB%87m_l%C3%A2m_s%C3%A0ng" title="Thử nghiệm lâm sàng – Vietnamese" lang="vi" hreflang="vi" data-title="Thử nghiệm lâm sàng" data-language-autonym="Tiếng Việt" data-language-local-name="Vietnamese" class="interlanguage-link-target"><span>Tiếng Việt</span></a></li><li class="interlanguage-link interwiki-zh-yue mw-list-item"><a href="https://zh-yue.wikipedia.org/wiki/%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97" title="臨床試驗 – Cantonese" lang="yue" hreflang="yue" data-title="臨床試驗" data-language-autonym="粵語" data-language-local-name="Cantonese" class="interlanguage-link-target"><span>粵語</span></a></li><li class="interlanguage-link interwiki-zh mw-list-item"><a href="https://zh.wikipedia.org/wiki/%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97" title="臨床試驗 – Chinese" lang="zh" hreflang="zh" data-title="臨床試驗" data-language-autonym="中文" data-language-local-name="Chinese" class="interlanguage-link-target"><span>中文</span></a></li> </ul> <div class="after-portlet after-portlet-lang"><span class="wb-langlinks-edit wb-langlinks-link"><a href="https://www.wikidata.org/wiki/Special:EntityPage/Q30612#sitelinks-wikipedia" title="Edit 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trials</a>)</span></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Phase of clinical research in medicine</div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable">"Clinical Trials" redirects here. For the journal, see <a href="/wiki/Clinical_Trials_(journal)" title="Clinical Trials (journal)">Clinical Trials (journal)</a>.</div> <p class="mw-empty-elt"> </p> <figure class="mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Clinical_Trial_Participant_Receives_Injection_(34033294061).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg/230px-Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg" decoding="async" width="230" height="325" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg/345px-Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg/460px-Clinical_Trial_Participant_Receives_Injection_%2834033294061%29.jpg 2x" data-file-width="1157" data-file-height="1637" /></a><figcaption>A clinical trial participant receives an injection.</figcaption></figure> <p><b>Clinical trials</b> are prospective biomedical or behavioral research studies on <a href="/wiki/Human_subject_research" title="Human subject research">human participants</a> designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel <a href="/wiki/Vaccine" title="Vaccine">vaccines</a>, <a href="/wiki/Pharmaceutical_drug" class="mw-redirect" title="Pharmaceutical drug">drugs</a>, <a href="/wiki/Medical_nutrition_therapy" class="mw-redirect" title="Medical nutrition therapy">dietary choices</a>, <a href="/wiki/Dietary_supplement" title="Dietary supplement">dietary supplements</a>, and <a href="/wiki/Medical_device" title="Medical device">medical devices</a>) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy.<sup id="cite_ref-nih-basics_1-0" class="reference"><a href="#cite_note-nih-basics-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-gates_2-0" class="reference"><a href="#cite_note-gates-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> They are conducted only after they have received <a href="/wiki/Institutional_review_board" title="Institutional review board">health authority/ethics committee</a> approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the <a href="/wiki/Risk/benefit_ratio" class="mw-redirect" title="Risk/benefit ratio">risk/benefit ratio</a> of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. </p><p>Depending on product type and development stage, investigators initially enroll volunteers or patients into small <a href="/wiki/Pilot_experiment" title="Pilot experiment">pilot studies</a>, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or <a href="/wiki/Multicenter_trial" title="Multicenter trial">multiple centers</a>, in one country or in multiple countries. <a href="/wiki/Clinical_study_design" title="Clinical study design">Clinical study design</a> aims to ensure the <a href="/wiki/Validity_(statistics)" title="Validity (statistics)">scientific validity</a> and <a href="/wiki/Reproducibility" title="Reproducibility">reproducibility</a> of the results. </p><p>Costs for clinical trials can range into the billions of dollars per approved drug,<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> and the complete trial process to approval may require 7–15 years.<sup id="cite_ref-fda-process_4-0" class="reference"><a href="#cite_note-fda-process-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-cancer-uk_5-0" class="reference"><a href="#cite_note-cancer-uk-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> The sponsor may be a governmental organization or a <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutical</a>, <a href="/wiki/Biotechnology" title="Biotechnology">biotechnology</a> or medical-device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a <a href="/wiki/Contract_research_organization" title="Contract research organization">contract research organization</a> or a central laboratory. Only 10 percent of all drugs started in human clinical trials become <a href="/wiki/Approved_drug" title="Approved drug">approved drugs</a>.<sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> </p> <style data-mw-deduplicate="TemplateStyles:r886046785">.mw-parser-output .toclimit-2 .toclevel-1 ul,.mw-parser-output .toclimit-3 .toclevel-2 ul,.mw-parser-output .toclimit-4 .toclevel-3 ul,.mw-parser-output .toclimit-5 .toclevel-4 ul,.mw-parser-output .toclimit-6 .toclevel-5 ul,.mw-parser-output .toclimit-7 .toclevel-6 ul{display:none}</style><div class="toclimit-3"><meta property="mw:PageProp/toc" /></div> <div class="mw-heading mw-heading2"><h2 id="Overview">Overview</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=1" title="Edit section: Overview"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Trials_of_drugs">Trials of drugs</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=2" title="Edit section: Trials of drugs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Some clinical trials involve healthy subjects with no <a href="/wiki/Pre-existing_medical_conditions" class="mw-redirect" title="Pre-existing medical conditions">pre-existing medical conditions</a>. Other clinical trials pertain to people with specific health conditions who are willing to try an experimental treatment. Pilot experiments are conducted to gain insights for design of the clinical trial to follow.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>There are two goals to testing medical treatments: to learn whether they work well enough, called "efficacy", or "effectiveness"; and to learn whether they are safe enough, called "safety".<sup id="cite_ref-nih-basics_1-1" class="reference"><a href="#cite_note-nih-basics-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> Neither is an absolute criterion; both safety and efficacy are evaluated relative to how the treatment is intended to be used, what other treatments are available, and the severity of the disease or condition. The benefits must outweigh the risks.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup class="reference nowrap"><span title="Page / location: 8">: 8 </span></sup> For example, many drugs to treat cancer have severe side effects that would not be acceptable for an over-the-counter pain medication, yet the cancer drugs have been approved since they are used under a physician's care and are used for a life-threatening condition.<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> </p><p>In the US the elderly constitute 14% of the population, while they consume over one-third of drugs.<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> People over 55 (or a similar cutoff age) are often excluded from trials because their greater health issues and drug use complicate data interpretation, and because they have different physiological capacity than younger people. Children and people with unrelated medical conditions are also frequently excluded.<sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> Pregnant women are often excluded due to potential risks to the <a href="/wiki/Fetus" title="Fetus">fetus</a>. </p><p>The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative or existing treatments to compare to the new drug and what type(s) of patients might benefit. If the sponsor cannot obtain enough test subjects at one location investigators at other locations are recruited to join the study.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>During the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment(s) and collect data on the subjects' health for a defined time period. Data include measurements such as <a href="/wiki/Vital_signs" title="Vital signs">vital signs</a>, concentration of the study drug in the blood or tissues, changes to symptoms, and whether improvement or worsening of the condition targeted by the study drug occurs. The researchers send the data to the trial sponsor, who then analyzes the pooled data using <a href="/wiki/Statistical_hypothesis_testing" class="mw-redirect" title="Statistical hypothesis testing">statistical tests</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>Examples of clinical trial goals include assessing the safety and relative effectiveness of a medication or device:<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <ul><li>On a specific kind of patient</li> <li>At varying dosages</li> <li>For a new indication</li> <li>Evaluation for improved efficacy in treating a condition as compared to the standard therapy for that condition</li> <li>Evaluation of the study drug or device relative to two or more already approved/common interventions for that condition</li></ul> <p>While most clinical trials test one alternative to the novel intervention, some expand to three or four and may include a <a href="/wiki/Placebo" title="Placebo">placebo</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>Except for small, single-location trials, the design and objectives are specified in a document called a <a href="/wiki/Clinical_trial_protocol" class="mw-redirect" title="Clinical trial protocol">clinical trial protocol</a>. The protocol is the trial's "operating manual" and ensures all researchers perform the trial in the same way on similar subjects and that the data is comparable across all subjects.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>As a trial is designed to test <a href="/wiki/Hypothesis" title="Hypothesis">hypotheses</a> and rigorously monitor and assess outcomes, it can be seen as an application of the <a href="/wiki/Scientific_method" title="Scientific method">scientific method</a>, specifically the experimental step.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>The most common clinical trials evaluate new pharmaceutical products, medical devices, <a href="/wiki/Biologic_medical_product" class="mw-redirect" title="Biologic medical product">biologics</a>, <a href="/wiki/Medical_diagnosis" title="Medical diagnosis">diagnostic assays</a>, <a href="/wiki/Psychological_therapies" class="mw-redirect" title="Psychological therapies">psychological therapies</a>, or other interventions.<sup id="cite_ref-fda-types_12-0" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> Clinical trials may be required before a national <a href="/wiki/Regulatory_authority" class="mw-redirect" title="Regulatory authority">regulatory authority</a><sup id="cite_ref-reg-auth_13-0" class="reference"><a href="#cite_note-reg-auth-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> approves marketing of the innovation. </p> <div class="mw-heading mw-heading3"><h3 id="Trials_of_devices">Trials of devices</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=3" title="Edit section: Trials of devices"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Similarly to drugs, manufacturers of medical devices in the United States are required to conduct clinical trials for <a href="/wiki/Premarket_approval" class="mw-redirect" title="Premarket approval">premarket approval</a>.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> Device trials may compare a new device to an established therapy, or may compare similar devices to each other. An example of the former in the field of <a href="/wiki/Vascular_surgery" title="Vascular surgery">vascular surgery</a> is the Open versus Endovascular Repair (OVER trial) for the treatment of <a href="/wiki/Abdominal_aortic_aneurysm" title="Abdominal aortic aneurysm">abdominal aortic aneurysm</a>, which compared the older <a href="/wiki/Open_aortic_repair" class="mw-redirect" title="Open aortic repair">open aortic repair</a> technique to the newer <a href="/wiki/Endovascular_aneurysm_repair" title="Endovascular aneurysm repair">endovascular aneurysm repair</a> device.<sup id="cite_ref-OVER_15-0" class="reference"><a href="#cite_note-OVER-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> An example of the latter are clinical trials on mechanical devices used in the management of adult female <a href="/wiki/Urinary_incontinence" title="Urinary incontinence">urinary incontinence</a>.<sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Trials_of_procedures">Trials of procedures</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=4" title="Edit section: Trials of procedures"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Similarly to drugs, medical or surgical procedures may be subjected to clinical trials,<sup id="cite_ref-PROCEDURE_TRIALS_17-0" class="reference"><a href="#cite_note-PROCEDURE_TRIALS-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> such as comparing different surgical approaches in treatment of <a href="/wiki/Fibroma" title="Fibroma">fibroids</a> for <a href="/wiki/Infertility" title="Infertility">subfertility</a>.<sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> However, when clinical trials are unethical or logistically impossible in the surgical setting, <a href="/wiki/Case-control_study" class="mw-redirect" title="Case-control study">case-controlled studies</a> will be replaced.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Patient_and_public_involvement">Patient and public involvement</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=5" title="Edit section: Patient and public involvement"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Besides being participants in a clinical trial, members of the public can be actively collaborate with researchers in designing and conducting <a href="/wiki/Clinical_research" title="Clinical research">clinical research</a>. This is known as <a href="/wiki/Patient_and_public_involvement" title="Patient and public involvement">patient and public involvement</a> (PPI). Public involvement involves a working partnership between patients, caregivers, people with lived experience, and researchers to shape and influence what is researcher and how.<sup id="cite_ref-:1_20-0" class="reference"><a href="#cite_note-:1-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> PPI can improve the quality of research and make it more relevant and accessible. People with current or past experience of illness can provide a different perspective than professionals and compliment their knowledge. Through their personal knowledge they can identify research topics that are relevant and important to those living with an illness or using a service. They can also help to make the research more grounded in the needs of the specific communities they are part of. Public contributors can also ensure that the research is presented in <a href="/wiki/Plain_language" title="Plain language">plain language</a> that is clear to the wider society and the specific groups it is most relevant for.<sup id="cite_ref-:02_21-0" class="reference"><a href="#cite_note-:02-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=6" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Development">Development</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=7" title="Edit section: Development"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure typeof="mw:File/Thumb"><a href="/wiki/File:Melingue_Jenner.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/6/6d/Melingue_Jenner.jpg/300px-Melingue_Jenner.jpg" decoding="async" width="300" height="306" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/6/6d/Melingue_Jenner.jpg/450px-Melingue_Jenner.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/6/6d/Melingue_Jenner.jpg/600px-Melingue_Jenner.jpg 2x" data-file-width="1400" data-file-height="1429" /></a><figcaption><a href="/wiki/Edward_Jenner" title="Edward Jenner">Edward Jenner</a> vaccinating <a href="/wiki/James_Phipps" title="James Phipps">James Phipps</a>, a boy of eight, on 14 May 1796. Jenner failed to use a <a href="/wiki/Control_group" class="mw-redirect" title="Control group">control group</a>.</figcaption></figure> <p>Although early medical experimentation was performed often, the use of a <a href="/wiki/Control_group" class="mw-redirect" title="Control group">control group</a> to provide an accurate comparison for the demonstration of the intervention's efficacy was generally lacking. For instance, <a href="/wiki/Lady_Mary_Wortley_Montagu" title="Lady Mary Wortley Montagu">Lady Mary Wortley Montagu</a>, who campaigned for the introduction of <a href="/wiki/Inoculation" title="Inoculation">inoculation</a> (then called variolation) to prevent <a href="/wiki/Smallpox" title="Smallpox">smallpox</a>, arranged for seven prisoners who had been sentenced to death to undergo variolation in exchange for their life. Although they survived and did not contract smallpox, there was no control group to assess whether this result was due to the inoculation or some other factor. Similar experiments performed by <a href="/wiki/Edward_Jenner" title="Edward Jenner">Edward Jenner</a> over his <a href="/wiki/Smallpox_vaccine" title="Smallpox vaccine">smallpox vaccine</a> were equally conceptually flawed.<sup id="cite_ref-MeinartTonascia_22-0" class="reference"><a href="#cite_note-MeinartTonascia-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p><p>The first proper clinical trial was conducted by the Scottish physician <a href="/wiki/James_Lind" title="James Lind">James Lind</a>.<sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> The disease <a href="/wiki/Scurvy" title="Scurvy">scurvy</a>, now known to be caused by a <a href="/wiki/Vitamin_C" title="Vitamin C">Vitamin C</a> deficiency, would often have terrible effects on the welfare of the crew of long-distance ocean voyages. In 1740, the catastrophic result of <a href="/wiki/George_Anson,_1st_Baron_Anson" title="George Anson, 1st Baron Anson">Anson</a>'s <a href="/wiki/George_Anson%27s_voyage_around_the_world" title="George Anson's voyage around the world">circumnavigation</a> attracted much attention in Europe; out of 1900 men, 1400 had died, most of them allegedly from having contracted scurvy.<sup id="cite_ref-24" class="reference"><a href="#cite_note-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> <a href="/wiki/John_Woodall" title="John Woodall">John Woodall</a>, an English military surgeon of the <a href="/wiki/British_East_India_Company" class="mw-redirect" title="British East India Company">British East India Company</a>, had recommended the consumption of <a href="/wiki/Citrus_fruit" class="mw-redirect" title="Citrus fruit">citrus fruit</a> from the 17th century, but their use did not become widespread.<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> </p><p>Lind conducted the first systematic <a href="/wiki/Controlled_experiment" class="mw-redirect" title="Controlled experiment">clinical trial</a> in 1747.<sup id="cite_ref-26" class="reference"><a href="#cite_note-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> He included a dietary supplement of an acidic quality in the experiment after two months at sea, when the ship was already afflicted with scurvy. He divided twelve scorbutic sailors into six groups of two. They all received the same diet but, in addition, group one was given a quart of <a href="/wiki/Cider" title="Cider">cider</a> daily, group two twenty-five drops of elixir of <a href="/wiki/Vitriol" title="Vitriol">vitriol</a> (<a href="/wiki/Sulfuric_acid" title="Sulfuric acid">sulfuric acid</a>), group three six spoonfuls of <a href="/wiki/Vinegar" title="Vinegar">vinegar</a>, group four half a pint of seawater, group five received two <a href="/wiki/Orange_(fruit)" title="Orange (fruit)">oranges</a> and one <a href="/wiki/Lemon" title="Lemon">lemon</a>, and the last group a spicy paste plus a drink of <a href="/wiki/Barley_water" title="Barley water">barley water</a>. The treatment of group five stopped after six days when they ran out of fruit, but by then one sailor was fit for duty while the other had almost recovered. Apart from that, only group one also showed some effect of its treatment.<sup id="cite_ref-27" class="reference"><a href="#cite_note-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> Each year, May 20 is celebrated as Clinical Trials Day in honor of Lind's research.<sup id="cite_ref-28" class="reference"><a href="#cite_note-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> </p><p>After 1750 the discipline began to take its modern shape.<sup id="cite_ref-GreenCrowley2002_29-0" class="reference"><a href="#cite_note-GreenCrowley2002-29"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Gad2009_30-0" class="reference"><a href="#cite_note-Gad2009-30"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup> The English doctor <a href="/wiki/John_Haygarth" title="John Haygarth">John Haygarth</a> demonstrated the importance of a control group for the correct identification of the <a href="/wiki/Placebo_effect" class="mw-redirect" title="Placebo effect">placebo effect</a> in his celebrated study of the ineffective remedy called <i><a href="/wiki/Elisha_Perkins" title="Elisha Perkins">Perkin's tractors</a></i>. Further work in that direction was carried out by the eminent physician <a href="/wiki/Sir_William_Gull,_1st_Baronet" class="mw-redirect" title="Sir William Gull, 1st Baronet">Sir William Gull, 1st Baronet</a> in the 1860s.<sup id="cite_ref-MeinartTonascia_22-1" class="reference"><a href="#cite_note-MeinartTonascia-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p><p><a href="/wiki/Frederick_Akbar_Mahomed" title="Frederick Akbar Mahomed">Frederick Akbar Mahomed</a> (d. 1884), who worked at <a href="/wiki/Guy%27s_Hospital" title="Guy's Hospital">Guy's Hospital</a> in <a href="/wiki/London" title="London">London</a>, made substantial contributions to the process of clinical trials, where "he separated chronic <a href="/wiki/Nephritis" title="Nephritis">nephritis</a> with <a href="/wiki/Secondary_hypertension" title="Secondary hypertension">secondary hypertension</a> from what we now term <a href="/wiki/Hypertension" title="Hypertension">essential hypertension</a>. He also founded the Collective Investigation Record for the <a href="/wiki/British_Medical_Association" title="British Medical Association">British Medical Association</a>; this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials."<sup id="cite_ref-MFOR_31-0" class="reference"><a href="#cite_note-MFOR-31"><span class="cite-bracket">[</span>31<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Modern_trials">Modern trials</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=8" title="Edit section: Modern trials"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Austin_Bradford_Hill.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/e/eb/Austin_Bradford_Hill.jpg/220px-Austin_Bradford_Hill.jpg" decoding="async" width="220" height="281" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/e/eb/Austin_Bradford_Hill.jpg/330px-Austin_Bradford_Hill.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/e/eb/Austin_Bradford_Hill.jpg/440px-Austin_Bradford_Hill.jpg 2x" data-file-width="1131" data-file-height="1447" /></a><figcaption><a href="/wiki/Austin_Bradford_Hill" title="Austin Bradford Hill">Austin Bradford Hill</a> was a pivotal figure in the modern development of clinical trials.</figcaption></figure> <p>Ideas of Sir <a href="/wiki/Ronald_A._Fisher" class="mw-redirect" title="Ronald A. Fisher">Ronald A. Fisher</a> still play a role in clinical trials. While working for the <a href="/wiki/Rothamsted_experimental_station" class="mw-redirect" title="Rothamsted experimental station">Rothamsted experimental station</a> in the field of agriculture, Fisher developed his <i>Principles of experimental design</i> in the 1920s as an accurate methodology for the proper design of experiments. Among his major ideas include the importance of <a href="/wiki/Randomized_experiment" title="Randomized experiment">randomization</a>—the random assignment of individuals to different groups for the experiment;<sup id="cite_ref-32" class="reference"><a href="#cite_note-32"><span class="cite-bracket">[</span>32<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Replication_(statistics)" title="Replication (statistics)">replication</a>—to reduce <a href="/wiki/Measurement_uncertainty" title="Measurement uncertainty">uncertainty</a>, measurements should be repeated and experiments replicated to identify sources of variation;<sup id="cite_ref-33" class="reference"><a href="#cite_note-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Blocking_(statistics)" title="Blocking (statistics)">blocking</a>—to arrange experimental units into groups of units that are similar to each other, and thus reducing irrelevant sources of variation; use of <a href="/wiki/Factorial_experiment" title="Factorial experiment">factorial experiments</a>—efficient at evaluating the effects and possible <a href="/wiki/Interaction_(statistics)" title="Interaction (statistics)">interactions</a> of several independent factors.<sup id="cite_ref-MeinartTonascia_22-2" class="reference"><a href="#cite_note-MeinartTonascia-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> Of these, blocking and factorial design are seldom applied in clinical trials, because the experimental units are human subjects and there is typically only one independent intervention: the treatment.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>The <a href="/wiki/Medical_Research_Council_(United_Kingdom)" title="Medical Research Council (United Kingdom)">British Medical Research Council</a> officially recognized the importance of clinical trials from the 1930s. The council established the <i>Therapeutic Trials Committee</i> to advise and assist in the arrangement of properly controlled clinical trials on new products that seem likely on experimental grounds to have value in the treatment of disease.<sup id="cite_ref-MeinartTonascia_22-3" class="reference"><a href="#cite_note-MeinartTonascia-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p><p>The first randomised curative trial was carried out at the MRC Tuberculosis Research Unit by Sir Geoffrey Marshall (1887–1982). The trial, carried out between 1946 and 1947, aimed to test the efficacy of the chemical <a href="/wiki/Streptomycin" title="Streptomycin">streptomycin</a> for curing <a href="/wiki/Pulmonary_tuberculosis" class="mw-redirect" title="Pulmonary tuberculosis">pulmonary tuberculosis</a>. The trial was both <a href="/wiki/Blind_experiment" class="mw-redirect" title="Blind experiment">double-blind</a> and <a href="/wiki/Placebo" title="Placebo">placebo-controlled</a>.<sup id="cite_ref-34" class="reference"><a href="#cite_note-34"><span class="cite-bracket">[</span>34<span class="cite-bracket">]</span></a></sup> </p><p>The methodology of clinical trials was further developed by Sir <a href="/wiki/Austin_Bradford_Hill" title="Austin Bradford Hill">Austin Bradford Hill</a>, who had been involved in the streptomycin trials. From the 1920s, Hill applied <a href="/wiki/Statistics" title="Statistics">statistics</a> to medicine, attending the lectures of renowned mathematician <a href="/wiki/Karl_Pearson" title="Karl Pearson">Karl Pearson</a>, among others. He became famous for a landmark study carried out in collaboration with <a href="/wiki/Richard_Doll" title="Richard Doll">Richard Doll</a> on the correlation between <a href="/wiki/Smoking" title="Smoking">smoking</a> and <a href="/wiki/Lung_cancer" title="Lung cancer">lung cancer</a>. They carried out a <a href="/wiki/Case-control_study" class="mw-redirect" title="Case-control study">case-control study</a> in 1950, which compared lung cancer patients with matched control and also began a sustained <a href="/wiki/Prospective_study" class="mw-redirect" title="Prospective study">long-term prospective study</a> into the broader issue of smoking and health, which involved <a href="/wiki/British_doctors_study" class="mw-redirect" title="British doctors study">studying the smoking habits and health of more than 30,000 doctors</a> over a period of several years. His certificate for election to the <a href="/wiki/Royal_Society" title="Royal Society">Royal Society</a> called him "...<span class="nowrap"> </span>the leader in the development in medicine of the precise experimental methods now used nationally and internationally in the evaluation of new therapeutic and <a href="/wiki/Prophylactic" class="mw-redirect" title="Prophylactic">prophylactic agents</a>." </p><p>International clinical trials day is celebrated on 20 May.<sup id="cite_ref-35" class="reference"><a href="#cite_note-35"><span class="cite-bracket">[</span>35<span class="cite-bracket">]</span></a></sup> </p><p>The acronyms used in the <a href="/wiki/Clinical_trial_naming_conventions" title="Clinical trial naming conventions">titling of clinical trials</a> are often contrived, and have been the subject of derision.<sup id="cite_ref-36" class="reference"><a href="#cite_note-36"><span class="cite-bracket">[</span>36<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Types">Types</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=9" title="Edit section: Types"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Clinical trials are classified by the research objective created by the investigators.<sup id="cite_ref-fda-types_12-1" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <ul><li>In an <a href="/wiki/Observational_study" title="Observational study">observational study</a>, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study.<sup id="cite_ref-ctgov_37-0" class="reference"><a href="#cite_note-ctgov-37"><span class="cite-bracket">[</span>37<span class="cite-bracket">]</span></a></sup></li> <li>In an <i>interventional study</i>, the investigators give the research subjects an experimental drug, surgical procedure, use of a medical device, diagnostic or other intervention to compare the treated subjects with those receiving no treatment or the standard treatment. Then the researchers assess how the subjects' health changes.<sup id="cite_ref-ctgov_37-1" class="reference"><a href="#cite_note-ctgov-37"><span class="cite-bracket">[</span>37<span class="cite-bracket">]</span></a></sup></li></ul> <p>Trials are classified by their purpose. After approval for human research is granted to the trial sponsor, the U.S. <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA) organizes and monitors the results of trials according to type:<sup id="cite_ref-fda-types_12-2" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <ul><li><i>Prevention</i> trials look for ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include <a href="/wiki/Prescription_drug" title="Prescription drug">drugs</a>, <a href="/wiki/Vitamin" title="Vitamin">vitamins</a> or other <a href="/wiki/Micronutrient" title="Micronutrient">micronutrients</a>, <a href="/wiki/Vaccine" title="Vaccine">vaccines</a>, or <a href="/wiki/Lifestyle_(sociology)" class="mw-redirect" title="Lifestyle (sociology)">lifestyle</a> changes.</li> <li><i>Screening</i> trials test for ways to identify certain diseases or health conditions.</li> <li><i>Diagnostic</i> trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.</li> <li><i>Treatment</i> trials test experimental drugs, new combinations of drugs, or new approaches to surgery or <a href="/wiki/Radiation_therapy" title="Radiation therapy">radiation therapy</a>.</li> <li><i><a href="/wiki/Quality_of_life_(healthcare)" title="Quality of life (healthcare)">Quality of life</a></i> trials (supportive care trials) evaluate how to improve comfort and quality of care for people with a <a href="/wiki/Chronic_illness" class="mw-redirect" title="Chronic illness">chronic illness</a>.</li> <li><i><a href="/wiki/Genetics" title="Genetics">Genetic</a></i> trials are conducted to assess the prediction accuracy of genetic disorders making a person more or less likely to develop a disease.</li> <li><i><a href="/wiki/Epidemiology" title="Epidemiology">Epidemiological</a></i> trials have the goal of identifying the general causes, patterns or control of diseases in large numbers of people.</li> <li><i>Compassionate use</i> trials or <a href="/wiki/Expanded_access" title="Expanded access">expanded access</a> trials provide partially tested, unapproved therapeutics to a small number of patients who have no other realistic options. Usually, this involves a disease for which no effective therapy has been approved, or a patient who has already failed all standard treatments and whose health is too compromised to qualify for participation in randomized clinical trials.<sup id="cite_ref-38" class="reference"><a href="#cite_note-38"><span class="cite-bracket">[</span>38<span class="cite-bracket">]</span></a></sup> Usually, case-by-case approval must be granted by both the FDA and the pharmaceutical company for such exceptions.</li> <li>Fixed trials consider existing data only during the trial's design, do not modify the trial after it begins, and do not assess the results until the study is completed.</li> <li><a href="/wiki/Adaptive_clinical_trial" class="mw-redirect" title="Adaptive clinical trial">Adaptive clinical trials</a> use existing data to design the trial, and then use interim results to modify the trial as it proceeds. Modifications include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix.<sup id="cite_ref-39" class="reference"><a href="#cite_note-39"><span class="cite-bracket">[</span>39<span class="cite-bracket">]</span></a></sup> Adaptive trials often employ a <a href="/wiki/Bayesian_experimental_design" title="Bayesian experimental design">Bayesian experimental design</a> to assess the trial's progress. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained.<sup id="cite_ref-news1309_40-0" class="reference"><a href="#cite_note-news1309-40"><span class="cite-bracket">[</span>40<span class="cite-bracket">]</span></a></sup> The aim is to more quickly identify drugs that have a therapeutic effect and to zero in on patient populations for whom the drug is appropriate.<sup id="cite_ref-wsj1401_41-0" class="reference"><a href="#cite_note-wsj1401-41"><span class="cite-bracket">[</span>41<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Huber2013_42-0" class="reference"><a href="#cite_note-Huber2013-42"><span class="cite-bracket">[</span>42<span class="cite-bracket">]</span></a></sup></li></ul> <p>Clinical trials are conducted typically in four phases, with each phase using different numbers of subjects and having a different purpose to construct focus on identifying a specific effect.<sup id="cite_ref-fda-types_12-3" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Phases">Phases</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=10" title="Edit section: Phases"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Phases_of_clinical_research" title="Phases of clinical research">Phases of clinical research</a></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><span><video id="mwe_player_0" poster="//upload.wikimedia.org/wikipedia/commons/thumb/4/4a/What_are_clinical_trial_phases.webm/220px--What_are_clinical_trial_phases.webm.jpg" controls="" preload="none" data-mw-tmh="" class="mw-file-element" width="220" height="124" data-durationhint="111" data-mwtitle="What_are_clinical_trial_phases.webm" data-mwprovider="wikimediacommons" resource="/wiki/File:What_are_clinical_trial_phases.webm"><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.480p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="480p.vp9.webm" data-width="854" data-height="480" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.720p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="720p.vp9.webm" data-width="1280" data-height="720" /><source src="//upload.wikimedia.org/wikipedia/commons/4/4a/What_are_clinical_trial_phases.webm" type="video/webm; codecs="vp9, opus"" data-width="1920" data-height="1080" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.1080p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="1080p.vp9.webm" data-width="1920" data-height="1080" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.240p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="240p.vp9.webm" data-width="426" data-height="240" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.360p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="360p.vp9.webm" data-width="640" data-height="360" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/4/4a/What_are_clinical_trial_phases.webm/What_are_clinical_trial_phases.webm.360p.webm" type="video/webm; codecs="vp8, vorbis"" data-transcodekey="360p.webm" data-width="640" data-height="360" /></video></span><figcaption><a href="/wiki/National_Cancer_Institute" title="National Cancer Institute">National Cancer Institute</a> video on the phases of clinical trials</figcaption></figure> <p>Clinical trials involving new drugs are commonly classified into five phases. Each phase of the drug approval process is treated as a separate clinical trial. The <a href="/wiki/Drug_development" title="Drug development">drug development</a> process will normally proceed through phases I–IV over many years, frequently involving a <a href="/wiki/Decade" title="Decade">decade</a> or longer. If the drug successfully passes through phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.<sup id="cite_ref-fda-types_12-4" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> Phase IV trials are performed after the newly approved drug, diagnostic or device is marketed, providing assessment about risks, benefits, or best uses.<sup id="cite_ref-fda-types_12-5" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <dl><dd><table class="wikitable"> <tbody><tr> <th>Phase</th> <th>Aim</th> <th>Notes </th></tr> <tr> <td>Phase 0</td> <td><a href="/wiki/Pharmacodynamics" title="Pharmacodynamics">Pharmacodynamics</a> and <a href="/wiki/Pharmacokinetics" title="Pharmacokinetics">pharmacokinetics</a> in humans</td> <td>Phase 0 trials are optional first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (typically 10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).<sup id="cite_ref-43" class="reference"><a href="#cite_note-43"><span class="cite-bracket">[</span>43<span class="cite-bracket">]</span></a></sup> For a test drug, the trial documents the absorption, distribution, metabolization, and clearance (excretion) of the drug, and the drug's interactions within the body, to confirm that these appear to be as expected. </td></tr> <tr> <td>Phase I</td> <td>Screening for safety</td> <td>Often are first-in-person trials. Testing within a small group of people (typically 20–80) to evaluate safety, determine safe dosage ranges, and identify <a href="/wiki/Side_effect" title="Side effect">side effects</a>.<sup id="cite_ref-fda-types_12-6" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </td></tr> <tr> <td>Phase II</td> <td>Establishing the preliminary efficacy of the drug in a <a href="/wiki/Treatment_and_control_groups" title="Treatment and control groups">"treatment group"</a>, usually against a <a href="/wiki/Placebo" title="Placebo">placebo</a> <a href="/wiki/Treatment_and_control_groups" title="Treatment and control groups">control group</a></td> <td>Phase II-a is specifically designed to assess dosing requirements (how much drug should be given),<sup id="cite_ref-fda-types_12-7" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-:0_44-0" class="reference"><a href="#cite_note-:0-44"><span class="cite-bracket">[</span>44<span class="cite-bracket">]</span></a></sup> while a Phase II-b trial is designed to determine efficacy (100–300 people),<sup id="cite_ref-nih-basics_1-2" class="reference"><a href="#cite_note-nih-basics-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> assessing how well the drug works at the prescribed dose(s) to establish a therapeutic dose range and monitor for possible side effects.<sup id="cite_ref-:0_44-1" class="reference"><a href="#cite_note-:0-44"><span class="cite-bracket">[</span>44<span class="cite-bracket">]</span></a></sup> </td></tr> <tr> <td>Phase III</td> <td>Final confirmation of safety and efficacy</td> <td>Testing with large groups of people (typically 1,000–3,000) to confirm drug efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.<sup id="cite_ref-fda-types_12-8" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </td></tr> <tr> <td>Phase IV</td> <td>Safety studies during sales</td> <td>Postmarketing studies delineate risks, benefits, and optimal use. As such, they are ongoing during the drug's lifetime of active medical use.<sup id="cite_ref-fda-types_12-9" class="reference"><a href="#cite_note-fda-types-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </td></tr></tbody></table></dd></dl> <div class="mw-heading mw-heading2"><h2 id="Trial_design">Trial design</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=11" title="Edit section: Trial design"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Clinical_study_design" title="Clinical study design">Clinical study design</a></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><span><video id="mwe_player_1" poster="//upload.wikimedia.org/wikipedia/commons/thumb/8/8e/Randomization_in_clinical_trials.webm/220px--Randomization_in_clinical_trials.webm.jpg" controls="" preload="none" data-mw-tmh="" class="mw-file-element" width="220" height="124" data-durationhint="93" data-mwtitle="Randomization_in_clinical_trials.webm" data-mwprovider="wikimediacommons" resource="/wiki/File:Randomization_in_clinical_trials.webm"><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.480p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="480p.vp9.webm" data-width="854" data-height="480" /><source src="//upload.wikimedia.org/wikipedia/commons/8/8e/Randomization_in_clinical_trials.webm" type="video/webm; codecs="vp9, opus"" data-width="1920" data-height="1080" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.720p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="720p.vp9.webm" data-width="1280" data-height="720" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.1080p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="1080p.vp9.webm" data-width="1920" data-height="1080" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.240p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="240p.vp9.webm" data-width="426" data-height="240" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.360p.vp9.webm" type="video/webm; codecs="vp9, opus"" data-transcodekey="360p.vp9.webm" data-width="640" data-height="360" /><source src="//upload.wikimedia.org/wikipedia/commons/transcoded/8/8e/Randomization_in_clinical_trials.webm/Randomization_in_clinical_trials.webm.360p.webm" type="video/webm; codecs="vp8, vorbis"" data-transcodekey="360p.webm" data-width="640" data-height="360" /></video></span><figcaption><a href="/wiki/National_Cancer_Institute" title="National Cancer Institute">National Cancer Institute</a> video on clinical trial randomization</figcaption></figure> <p>A fundamental distinction in <a href="/wiki/Evidence-based_practice" title="Evidence-based practice">evidence-based practice</a> is between <a href="/wiki/Observational_studies" class="mw-redirect" title="Observational studies">observational studies</a> and <a href="/wiki/Randomized_controlled_trial" title="Randomized controlled trial">randomized controlled trials</a>.<sup id="cite_ref-hannan_45-0" class="reference"><a href="#cite_note-hannan-45"><span class="cite-bracket">[</span>45<span class="cite-bracket">]</span></a></sup> Types of observational studies in <a href="/wiki/Epidemiology" title="Epidemiology">epidemiology</a>, such as the <a href="/wiki/Cohort_study" title="Cohort study">cohort study</a> and the <a href="/wiki/Case-control_study" class="mw-redirect" title="Case-control study">case-control study</a>, provide less compelling evidence than the randomized controlled trial.<sup id="cite_ref-hannan_45-1" class="reference"><a href="#cite_note-hannan-45"><span class="cite-bracket">[</span>45<span class="cite-bracket">]</span></a></sup> In observational studies, the investigators retrospectively assess associations between the treatments given to participants and their health status, with potential for considerable errors in design and interpretation.<sup id="cite_ref-sessler_46-0" class="reference"><a href="#cite_note-sessler-46"><span class="cite-bracket">[</span>46<span class="cite-bracket">]</span></a></sup> </p><p>A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.<sup id="cite_ref-hannan_45-2" class="reference"><a href="#cite_note-hannan-45"><span class="cite-bracket">[</span>45<span class="cite-bracket">]</span></a></sup> </p><p>Some Phase II and most Phase III drug trials are designed as randomized, <a href="/wiki/Blind_experiment" class="mw-redirect" title="Blind experiment">double-blind</a>, and <a href="/wiki/Placebo" title="Placebo">placebo</a>-controlled.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <ul><li>Randomized: Each study subject is randomly assigned to receive either the study treatment or a placebo.</li> <li>Blind: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment a subject receives. This intent is to prevent researchers from treating the two groups differently. A form of double-blind study called a "double-dummy" design allows additional insurance against bias. In this kind of study, all patients are given both placebo and active doses in alternating periods.</li> <li>Placebo-controlled: The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment from the <a href="/wiki/Placebo_effect" class="mw-redirect" title="Placebo effect">placebo effect</a>.</li></ul> <p>Clinical studies having small numbers of subjects may be "sponsored" by single researchers or a small group of researchers, and are designed to test simple questions or feasibility to expand the research for a more comprehensive randomized controlled trial.<sup id="cite_ref-eldridge_47-0" class="reference"><a href="#cite_note-eldridge-47"><span class="cite-bracket">[</span>47<span class="cite-bracket">]</span></a></sup> </p><p>Clinical studies can be "sponsored" (financed and organized) by academic institutions, pharmaceutical companies, government entities and even private groups. Trials are conducted for new drugs, biotechnology, diagnostic assays or medical devices to determine their safety and efficacy prior to being submitted for regulatory review that would determine market approval.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Active_control_studies">Active control studies</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=12" title="Edit section: Active control studies"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In cases where giving a placebo to a person suffering from a disease may be unethical, "active comparator" (also known as "active control") trials may be conducted instead.<sup id="cite_ref-48" class="reference"><a href="#cite_note-48"><span class="cite-bracket">[</span>48<span class="cite-bracket">]</span></a></sup> In trials with an active control group, subjects are given either the experimental treatment or a previously approved treatment with known effectiveness. In other cases, sponsors may conduct an active comparator trial to establish an efficacy claim relative to the active comparator instead of the placebo in <a href="/wiki/Drug_labelling" title="Drug labelling">labeling</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Master_protocol">Master protocol</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=13" title="Edit section: Master protocol"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>A master protocol includes multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more medical products in one or more diseases or conditions within the overall study structure. Trials that could develop a master protocol include the umbrella trial (multiple medical products for a single disease), <a href="/wiki/Platform_trial" title="Platform trial">platform trial</a> (multiple products for a single disease entering and leaving the platform), and basket trial (one medical product for multiple diseases or disease subtypes).<sup id="cite_ref-49" class="reference"><a href="#cite_note-49"><span class="cite-bracket">[</span>49<span class="cite-bracket">]</span></a></sup> </p><p><a href="/wiki/Genetic_testing" title="Genetic testing">Genetic testing</a> enables researchers to group patients according to their genetic profile, deliver drugs based on that profile to that group and compare the results. Multiple companies can participate, each bringing a different drug. The first such approach targets <a href="/wiki/Squamous_cell_cancer" class="mw-redirect" title="Squamous cell cancer">squamous cell cancer</a>, which includes varying genetic disruptions from patient to patient. Amgen, AstraZeneca and Pfizer are involved, the first time they have worked together in a late-stage trial. Patients whose genomic profiles do not match any of the trial drugs receive a drug designed to stimulate the immune system to attack cancer.<sup id="cite_ref-50" class="reference"><a href="#cite_note-50"><span class="cite-bracket">[</span>50<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Clinical_trial_protocol">Clinical trial protocol</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=14" title="Edit section: Clinical trial protocol"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Clinical_trial_protocol" class="mw-redirect" title="Clinical trial protocol">Clinical trial protocol</a></div> <p>A <a href="/wiki/Clinical_trial_protocol" class="mw-redirect" title="Clinical trial protocol">clinical trial protocol</a> is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. Details of the trial are provided in documents referenced in the protocol, such as an <a href="/wiki/Investigator%27s_brochure" title="Investigator's brochure">investigator's brochure</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>The protocol contains a precise study plan to assure safety and health of the trial subjects and to provide an exact template for trial conduct by investigators. This allows data to be combined across all investigators/sites. The protocol also informs the study administrators (often a <a href="/wiki/Contract_research_organization" title="Contract research organization">contract research organization</a>).<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance<sup id="cite_ref-51" class="reference"><a href="#cite_note-51"><span class="cite-bracket">[</span>51<span class="cite-bracket">]</span></a></sup> issued by the <a href="/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use" class="mw-redirect" title="International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use">International Conference on Harmonisation</a> (ICH).<sup id="cite_ref-52" class="reference"><a href="#cite_note-52"><span class="cite-bracket">[</span>52<span class="cite-bracket">]</span></a></sup> Regulatory authorities in <a href="/wiki/Health_Canada" title="Health Canada">Canada</a>, <a href="/wiki/National_Medical_Products_Administration" title="National Medical Products Administration">China</a>, <a href="/wiki/Ministry_of_Food_and_Drug_Safety" title="Ministry of Food and Drug Safety">South Korea</a>, and <a href="/wiki/Medicines_and_Healthcare_products_Regulatory_Agency" title="Medicines and Healthcare products Regulatory Agency">the UK</a> also follow ICH guidelines. Journals such as <i><a href="/wiki/Trials_(journal)" title="Trials (journal)">Trials</a></i>, encourage investigators to publish their protocols. </p> <div class="mw-heading mw-heading3"><h3 id="Design_features">Design features</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=15" title="Edit section: Design features"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading4"><h4 id="Informed_consent">Informed consent</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=16" title="Edit section: Informed consent"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/7/7f/PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu/page1-220px-PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu.jpg" decoding="async" width="220" height="285" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/7/7f/PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu/page1-330px-PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/7/7f/PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu/page1-440px-PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu.jpg 2x" data-file-width="2550" data-file-height="3301" /></a><figcaption>Example of informed consent document from the <a href="/wiki/PARAMOUNT_trial" title="PARAMOUNT trial">PARAMOUNT trial</a></figcaption></figure> <p>Clinical trials recruit study subjects to sign a document representing their "<a href="/wiki/Informed_consent" title="Informed consent">informed consent</a>".<sup id="cite_ref-what_53-0" class="reference"><a href="#cite_note-what-53"><span class="cite-bracket">[</span>53<span class="cite-bracket">]</span></a></sup> The document includes details such as its purpose, duration, required procedures, risks, potential benefits, key contacts and institutional requirements.<sup id="cite_ref-54" class="reference"><a href="#cite_note-54"><span class="cite-bracket">[</span>54<span class="cite-bracket">]</span></a></sup> The participant then decides whether to sign the document. The document is not a contract, as the participant can withdraw at any time without penalty.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p><p>Informed consent is a legal process in which a recruit is instructed about key facts before deciding whether to participate.<sup id="cite_ref-what_53-1" class="reference"><a href="#cite_note-what-53"><span class="cite-bracket">[</span>53<span class="cite-bracket">]</span></a></sup> Researchers explain the details of the study in terms the subject can understand. The information is presented in the subject's native language. Generally, children cannot autonomously provide informed consent, but depending on their age and other factors, may be required to provide informed assent.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading4"><h4 id="Statistical_power">Statistical power</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=17" title="Edit section: Statistical power"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In any clinical trial, the number of subjects, also called the sample size, has a large impact on the ability to reliably detect and measure the effects of the intervention. This ability is described as its "<a href="/wiki/Statistical_power" class="mw-redirect" title="Statistical power">power</a>", which must be calculated before initiating a study to figure out if the study is worth its costs.<sup id="cite_ref-55" class="reference"><a href="#cite_note-55"><span class="cite-bracket">[</span>55<span class="cite-bracket">]</span></a></sup> In general, a larger sample size increases the statistical power, also the cost. </p><p>The statistical power estimates the ability of a trial to detect a difference of a particular size (or larger) between the treatment and control groups. For example, a trial of a <a href="/wiki/Lipids" class="mw-redirect" title="Lipids">lipid</a>-lowering drug versus placebo with 100 patients in each group might have a power of 0.90 to detect a difference between placebo and trial groups receiving dosage of 10 mg/dL or more, but only 0.70 to detect a difference of 6 mg/dL.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Placebo_groups">Placebo groups</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=18" title="Edit section: Placebo groups"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Placebo-controlled_studies" class="mw-redirect" title="Placebo-controlled studies">Placebo-controlled studies</a></div> <p>Merely giving a treatment can have nonspecific effects. These are controlled for by the inclusion of patients who receive only a placebo. Subjects are assigned <a href="/wiki/Randomized_controlled_trial" title="Randomized controlled trial">randomly</a> without informing them to which group they belonged. Many trials are doubled-blinded so that researchers do not know to which group a subject is assigned. </p><p>Assigning a subject to a placebo group can pose an ethical problem if it violates his or her right to receive the best available treatment. The <a href="/wiki/Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a> provides guidelines on this issue. </p> <div class="mw-heading mw-heading3"><h3 id="Duration">Duration</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=19" title="Edit section: Duration"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-halign-center" typeof="mw:File/Thumb"><a href="/wiki/File:Drug_Evaluation_Process.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/8/87/Drug_Evaluation_Process.jpg/900px-Drug_Evaluation_Process.jpg" decoding="async" width="900" height="318" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/87/Drug_Evaluation_Process.jpg/1350px-Drug_Evaluation_Process.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/8/87/Drug_Evaluation_Process.jpg 2x" data-file-width="1433" data-file-height="507" /></a><figcaption>Timeline of various approval tracks and research phases in the US</figcaption></figure> <p>Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever undergoing clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial.<sup id="cite_ref-56" class="reference"><a href="#cite_note-56"><span class="cite-bracket">[</span>56<span class="cite-bracket">]</span></a></sup> For example, a new cancer drug has, on average, six years of research behind it before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is the time it takes to complete clinical trials themselves. On average, about eight years pass from the time a cancer drug enters clinical trials until it receives approval from regulatory agencies for sale to the public.<sup id="cite_ref-57" class="reference"><a href="#cite_note-57"><span class="cite-bracket">[</span>57<span class="cite-bracket">]</span></a></sup> Drugs for other diseases have similar timelines. </p><p>Some reasons a clinical trial might last several years: </p> <ul><li>For chronic conditions such as cancer, it takes months, if not years, to see if a cancer treatment has an effect on a patient.</li> <li>For drugs that are not expected to have a strong effect (meaning a large number of patients must be recruited to observe 'any' effect), recruiting enough patients to test the drug's effectiveness (i.e., getting statistical power) can take several years.</li> <li>Only certain people who have the target disease condition are eligible to take part in each clinical trial. Researchers who treat these particular patients must participate in the trial. Then they must identify the desirable patients and obtain consent from them or their families to take part in the trial.</li></ul> <p>A clinical trial might also include an extended post-study follow-up period from months to years for people who have participated in the trial, a so-called "extension phase", which aims to identify long-term impact of the treatment.<sup id="cite_ref-58" class="reference"><a href="#cite_note-58"><span class="cite-bracket">[</span>58<span class="cite-bracket">]</span></a></sup> </p><p>The biggest barrier to completing studies is the shortage of people who take part. All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit (because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo). In the case of cancer patients, fewer than 5% of adults with cancer will participate in drug trials. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), about 400 cancer medicines were being tested in clinical trials in 2005. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.<sup id="cite_ref-59" class="reference"><a href="#cite_note-59"><span class="cite-bracket">[</span>59<span class="cite-bracket">]</span></a></sup> </p><p>For clinical trials involving potential for seasonal influences (such as <a href="/wiki/Aeroallergen" title="Aeroallergen">airborne allergies</a>, <a href="/wiki/Seasonal_affective_disorder" title="Seasonal affective disorder">seasonal affective disorder</a>, <a href="/wiki/Influenza" title="Influenza">influenza</a>, and <a href="/wiki/Skin_disease" class="mw-redirect" title="Skin disease">skin diseases</a>), the study may be done during a limited part of the year (such as spring for pollen allergies), when the drug can be tested.<sup id="cite_ref-60" class="reference"><a href="#cite_note-60"><span class="cite-bracket">[</span>60<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-61" class="reference"><a href="#cite_note-61"><span class="cite-bracket">[</span>61<span class="cite-bracket">]</span></a></sup> </p><p>Clinical trials that do not involve a new drug usually have a much shorter duration. (Exceptions are epidemiological studies, such as the <a href="/wiki/Nurses%27_Health_Study" title="Nurses' Health Study">Nurses' Health Study</a>). </p> <div class="mw-heading mw-heading2"><h2 id="Administration">Administration</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=20" title="Edit section: Administration"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Clinical trials designed by a local investigator, and (in the US) federally funded clinical trials, are almost always administered by the researcher who designed the study and applied for the grant. Small-scale device studies may be administered by the sponsoring company. Clinical trials of new drugs are usually administered by a <a href="/wiki/Contract_research_organization" title="Contract research organization">contract research organization</a> (CRO) hired by the sponsoring company. The sponsor provides the drug and medical oversight. A CRO is contracted to perform all the administrative work on a clinical trial. For Phases<span class="nowrap"> </span>II–IV the CRO recruits participating researchers, trains them, provides them with supplies, coordinates study administration and <a href="/wiki/Data_collection" title="Data collection">data collection</a>, sets up meetings, monitors the sites for compliance with the clinical protocol, and ensures the sponsor receives data from every site. Specialist <a href="/wiki/Site_management_organization" title="Site management organization">site management organizations</a> can also be hired to coordinate with the CRO to ensure rapid IRB/IEC approval and faster site initiation and patient recruitment. Phase<span class="nowrap"> </span>I clinical trials of new medicines are often conducted in a specialist clinical trial clinic, with dedicated pharmacologists, where the subjects can be observed by full-time staff. These clinics are often run by a CRO which specialises in these studies. </p><p>At a participating site, one or more research assistants (often nurses) do most of the work in conducting the clinical trial. The research assistant's job can include some or all of the following: providing the local <a href="/wiki/Institutional_review_board" title="Institutional review board">institutional review board</a> (IRB) with the documentation necessary to obtain its permission to conduct the study, assisting with study start-up, identifying eligible patients, obtaining consent from them or their families, administering study treatment(s), collecting and statistically analyzing data, maintaining and updating data files during followup, and communicating with the IRB, as well as the sponsor and CRO. </p> <div class="mw-heading mw-heading3"><h3 id="Quality">Quality</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=21" title="Edit section: Quality"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the context of a clinical trial, quality typically refers to the absence of errors which can impact decision making, both during the conduct of the trial and in use of the trial results.<sup id="cite_ref-62" class="reference"><a href="#cite_note-62"><span class="cite-bracket">[</span>62<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Marketing">Marketing</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=22" title="Edit section: Marketing"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>An Interactional Justice Model may be used to test the effects of willingness to talk with a doctor about clinical trial enrollment.<sup id="cite_ref-63" class="reference"><a href="#cite_note-63"><span class="cite-bracket">[</span>63<span class="cite-bracket">]</span></a></sup> Results found that potential clinical trial candidates were less likely to enroll in clinical trials if the patient is more willing to talk with their doctor. The reasoning behind this discovery may be patients are happy with their current care. Another reason for the negative relationship between perceived fairness and clinical trial enrollment is the lack of independence from the care provider. Results found that there is a positive relationship between a lack of willingness to talk with their doctor and clinical trial enrollment. Lack of willingness to talk about clinical trials with current care providers may be due to patients' independence from the doctor. Patients who are less likely to talk about clinical trials are more willing to use other sources of information to gain a better insight of alternative treatments. Clinical trial enrollment should be motivated to utilize websites and television advertising to inform the public about clinical trial enrollment. </p> <div class="mw-heading mw-heading3"><h3 id="Information_technology">Information technology</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=23" title="Edit section: Information technology"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The last decade has seen a proliferation of <a href="/wiki/Information_technology" title="Information technology">information technology</a> use in the planning and conduct of clinical trials. <a href="/wiki/Clinical_Trial_Management_System" class="mw-redirect" title="Clinical Trial Management System">Clinical trial management systems</a> are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites. Advanced analytics for identifying researchers and research sites with expertise in a given area utilize public and private information about ongoing research.<sup id="cite_ref-64" class="reference"><a href="#cite_note-64"><span class="cite-bracket">[</span>64<span class="cite-bracket">]</span></a></sup> Web-based <a href="/wiki/Electronic_data_capture" title="Electronic data capture">electronic data capture</a> (EDC) and <a href="/wiki/Clinical_data_management_system" title="Clinical data management system">clinical data management systems</a> are used in a majority of clinical trials<sup id="cite_ref-65" class="reference"><a href="#cite_note-65"><span class="cite-bracket">[</span>65<span class="cite-bracket">]</span></a></sup> to collect case report data from sites, manage its quality and prepare it for analysis. <a href="/wiki/Interactive_voice_response" title="Interactive voice response">Interactive voice response</a> systems are used by sites to register the enrollment of patients using a phone and to allocate patients to a particular treatment arm (although phones are being increasingly replaced with web-based (IWRS) tools which are sometimes part of the EDC system). While <a href="/wiki/Patient-reported_outcome" title="Patient-reported outcome">patient-reported outcome</a> were often paper based in the past, measurements are increasingly being collected using web portals or hand-held <a href="/wiki/Electronic_patient-reported_outcome" title="Electronic patient-reported outcome">ePRO</a> (or eDiary) devices, sometimes wireless.<sup id="cite_ref-66" class="reference"><a href="#cite_note-66"><span class="cite-bracket">[</span>66<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Statistical_packages" class="mw-redirect" title="Statistical packages">Statistical software</a> is used to analyze the collected data and prepare them for regulatory submission. Access to many of these applications are increasingly aggregated in web-based <a href="/wiki/Clinical_Trial_Portal" class="mw-redirect" title="Clinical Trial Portal">clinical trial portals</a>. In 2011, the FDA approved a Phase<span class="nowrap"> </span>I trial that used telemonitoring, also known as remote patient monitoring, to collect biometric data in patients' homes and transmit it electronically to the trial database. This technology provides many more data points and is far more convenient for patients, because they have fewer visits to trial sites. As noted below, decentralized clinical trials are those that do not require patients' physical presence at a site, and instead rely largely on digital health data collection, digital informed consent processes, and so on. </p> <div class="mw-heading mw-heading2"><h2 id="Analysis">Analysis</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=24" title="Edit section: Analysis"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">See also: <a href="/wiki/Analysis_of_clinical_trials" title="Analysis of clinical trials">Analysis of clinical trials</a></div> <p>A clinical trial produces data that could reveal quantitative differences between two or more interventions; <a href="/wiki/Statistics" title="Statistics">statistical analyses</a> are used to determine whether such differences are true, result from chance, or are the same as no treatment (placebo).<sup id="cite_ref-evans_67-0" class="reference"><a href="#cite_note-evans-67"><span class="cite-bracket">[</span>67<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-iom_68-0" class="reference"><a href="#cite_note-iom-68"><span class="cite-bracket">[</span>68<span class="cite-bracket">]</span></a></sup> Data from a clinical trial accumulate gradually over the trial duration, extending from months to years.<sup id="cite_ref-what_53-2" class="reference"><a href="#cite_note-what-53"><span class="cite-bracket">[</span>53<span class="cite-bracket">]</span></a></sup> Accordingly, results for participants recruited early in the study become available for analysis while subjects are still being assigned to treatment groups in the trial. Early analysis may allow the emerging evidence to assist decisions about whether to stop the study, or to reassign participants to the more successful segment of the trial.<sup id="cite_ref-evans_67-1" class="reference"><a href="#cite_note-evans-67"><span class="cite-bracket">[</span>67<span class="cite-bracket">]</span></a></sup> Investigators may also want to stop a trial when data analysis shows no treatment effect.<sup id="cite_ref-iom_68-1" class="reference"><a href="#cite_note-iom-68"><span class="cite-bracket">[</span>68<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Ethical_aspects">Ethical aspects</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=25" title="Edit section: Ethical aspects"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main articles: <a href="/wiki/Clinical_research_ethics" class="mw-redirect" title="Clinical research ethics">Clinical research ethics</a> and <a href="/wiki/Clinical_trials_publication" title="Clinical trials publication">Clinical trials publication</a></div> <p>Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. The local ethics committee has discretion on how it will supervise noninterventional studies (observational studies or those using already collected data). In the US, this body is called the <a href="/wiki/Institutional_Review_Board" class="mw-redirect" title="Institutional Review Board">Institutional Review Board</a> (IRB); in the EU, they are called <a href="/wiki/Ethics_committee_(European_Union)" title="Ethics committee (European Union)">Ethics committees</a>. Most IRBs are located at the local investigator's hospital or institution, but some sponsors allow the use of a central (independent/for profit) IRB for investigators who work at smaller institutions. </p><p>To be ethical, researchers must obtain the full and <a href="/wiki/Informed_consent" title="Informed consent">informed consent</a> of participating human subjects. (One of the IRB's main functions is to ensure potential patients are adequately informed about the clinical trial.) If the patient is unable to consent for him/herself, researchers can seek consent from the patient's legally authorized representative. In addition, the clinical trial participants must be made aware that they can withdraw from the clinical trial at any time without any adverse action taken against them.<sup id="cite_ref-69" class="reference"><a href="#cite_note-69"><span class="cite-bracket">[</span>69<span class="cite-bracket">]</span></a></sup> In <a href="/wiki/California" title="California">California</a>, the state has prioritized the individuals who can serve as the legally authorized representative.<sup id="cite_ref-70" class="reference"><a href="#cite_note-70"><span class="cite-bracket">[</span>70<span class="cite-bracket">]</span></a></sup> </p><p>In some US locations, the local IRB must certify researchers and their staff before they can conduct clinical trials. They must understand the federal patient privacy (<a href="/wiki/Health_Insurance_Portability_and_Accountability_Act" title="Health Insurance Portability and Accountability Act">HIPAA</a>) law and good clinical practice. The International Conference of Harmonisation Guidelines for Good Clinical Practice is a set of standards used internationally for the conduct of clinical trials. The guidelines aim to ensure the "rights, safety and well being of trial subjects are protected". </p><p>The notion of informed consent of participating human subjects exists in many countries but its precise definition may still vary. </p><p>Informed consent is clearly a 'necessary' condition for ethical conduct but does not 'ensure' ethical conduct. In <a href="/wiki/Compassionate_use" class="mw-redirect" title="Compassionate use">compassionate use</a> trials the latter becomes a particularly difficult problem. The final objective is to serve the community of patients or future patients in a best-possible and most responsible way. See also <a href="/wiki/Expanded_access" title="Expanded access">Expanded access</a>. However, it may be hard to turn this objective into a well-defined, quantified, objective function. In some cases this can be done, however, for instance, for questions of when to stop sequential treatments (see <a href="/wiki/Odds_algorithm" title="Odds algorithm">Odds algorithm</a>), and then quantified methods may play an important role. </p><p>Additional ethical concerns are present when conducting <a href="/wiki/Ethical_problems_using_children_in_clinical_trials" class="mw-redirect" title="Ethical problems using children in clinical trials">clinical trials on children</a> (<a href="/wiki/Pediatrics" title="Pediatrics">pediatrics</a>), and in emergency or epidemic situations.<sup id="cite_ref-71" class="reference"><a href="#cite_note-71"><span class="cite-bracket">[</span>71<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-72" class="reference"><a href="#cite_note-72"><span class="cite-bracket">[</span>72<span class="cite-bracket">]</span></a></sup> </p><p>Ethically balancing the rights of multiple stakeholders may be difficult. For example, when drug trials fail, the sponsors may have a duty to tell current and potential investors immediately, which means both the research staff and the enrolled participants may first hear about the end of a trial through public <a href="/wiki/Business_news" class="mw-redirect" title="Business news">business news</a>.<sup id="cite_ref-73" class="reference"><a href="#cite_note-73"><span class="cite-bracket">[</span>73<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Conflicts_of_interest_and_unfavorable_studies">Conflicts of interest and unfavorable studies</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=26" title="Edit section: Conflicts of interest and unfavorable studies"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research were not published, the <a href="/wiki/Pharmaceutical_Research_and_Manufacturers_of_America" title="Pharmaceutical Research and Manufacturers of America">Pharmaceutical Research and Manufacturers of America</a> published new guidelines urging companies to report all findings and limit the financial involvement in drug companies by researchers.<sup id="cite_ref-moynihanbmj_74-0" class="reference"><a href="#cite_note-moynihanbmj-74"><span class="cite-bracket">[</span>74<span class="cite-bracket">]</span></a></sup> The <a href="/wiki/US_Congress" class="mw-redirect" title="US Congress">US Congress</a> signed into law a bill which requires Phase<span class="nowrap"> </span>II and Phase<span class="nowrap"> </span>III clinical trials to be registered by the sponsor on the <a href="/wiki/Clinicaltrials.gov" class="mw-redirect" title="Clinicaltrials.gov">clinicaltrials.gov</a> website compiled by the <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a>.<sup id="cite_ref-75" class="reference"><a href="#cite_note-75"><span class="cite-bracket">[</span>75<span class="cite-bracket">]</span></a></sup> </p><p>Drug researchers not directly employed by pharmaceutical companies often seek grants from manufacturers, and manufacturers often look to academic researchers to conduct studies within networks of universities and their hospitals, e.g., for <a href="/wiki/Translational_research" title="Translational research">translational</a> cancer research. Similarly, competition for tenured academic positions, government grants and prestige create conflicts of interest among academic scientists.<sup id="cite_ref-76" class="reference"><a href="#cite_note-76"><span class="cite-bracket">[</span>76<span class="cite-bracket">]</span></a></sup> According to one study, approximately 75% of articles retracted for misconduct-related reasons have no declared industry financial support.<sup id="cite_ref-77" class="reference"><a href="#cite_note-77"><span class="cite-bracket">[</span>77<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Seeding_trial" title="Seeding trial">Seeding trials</a> are particularly controversial.<sup id="cite_ref-Say_no_78-0" class="reference"><a href="#cite_note-Say_no-78"><span class="cite-bracket">[</span>78<span class="cite-bracket">]</span></a></sup> </p><p>In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration,<sup id="cite_ref-79" class="reference"><a href="#cite_note-79"><span class="cite-bracket">[</span>79<span class="cite-bracket">]</span></a></sup> including inspections of primary data collection at selected clinical trial sites.<sup id="cite_ref-80" class="reference"><a href="#cite_note-80"><span class="cite-bracket">[</span>80<span class="cite-bracket">]</span></a></sup> </p><p>In 2001, the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication. They strengthened editorial restrictions to counter the effect. The editorial noted that <a href="/wiki/Contract_research_organization" title="Contract research organization">contract research organizations</a> had, by 2000, received 60% of the grants from <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutical companies</a> in the US. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.<sup id="cite_ref-81" class="reference"><a href="#cite_note-81"><span class="cite-bracket">[</span>81<span class="cite-bracket">]</span></a></sup> </p><p>Despite explicit recommendations  by stakeholders of measures to improve the standards of industry-sponsored medical research,<sup id="cite_ref-82" class="reference"><a href="#cite_note-82"><span class="cite-bracket">[</span>82<span class="cite-bracket">]</span></a></sup>   in 2013, <a href="/wiki/Mauricio_Tohen" title="Mauricio Tohen">Tohen</a> warned of the persistence of a gap in the credibility of conclusions arising from industry-funded clinical trials, and called for ensuring strict adherence to ethical standards in industrial collaborations with academia, in order to avoid further erosion of the public's trust.<sup id="cite_ref-83" class="reference"><a href="#cite_note-83"><span class="cite-bracket">[</span>83<span class="cite-bracket">]</span></a></sup> Issues referred for attention in this respect include potential observation bias, duration of the observation time for maintenance studies, the selection of the patient populations, factors that affect placebo response, and funding sources.<sup id="cite_ref-84" class="reference"><a href="#cite_note-84"><span class="cite-bracket">[</span>84<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-85" class="reference"><a href="#cite_note-85"><span class="cite-bracket">[</span>85<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-86" class="reference"><a href="#cite_note-86"><span class="cite-bracket">[</span>86<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="During_public_health_crisis">During public health crisis</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=27" title="Edit section: During public health crisis"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Conducting clinical trials of vaccines during epidemics and pandemics is subject to ethical concerns. For diseases with high mortality rates like Ebola, assigning individuals to a placebo or control group can be viewed as a death sentence. In response to ethical concerns regarding clinical research during epidemics, the <a href="/wiki/National_Academy_of_Medicine" title="National Academy of Medicine">National Academy of Medicine</a> authored a report identifying seven ethical and scientific considerations. These considerations are:<sup id="cite_ref-Edwards_87-0" class="reference"><a href="#cite_note-Edwards-87"><span class="cite-bracket">[</span>87<span class="cite-bracket">]</span></a></sup> </p> <style data-mw-deduplicate="TemplateStyles:r1184024115">.mw-parser-output .div-col{margin-top:0.3em;column-width:30em}.mw-parser-output .div-col-small{font-size:90%}.mw-parser-output .div-col-rules{column-rule:1px solid #aaa}.mw-parser-output .div-col dl,.mw-parser-output .div-col ol,.mw-parser-output .div-col ul{margin-top:0}.mw-parser-output .div-col li,.mw-parser-output .div-col dd{page-break-inside:avoid;break-inside:avoid-column}</style><div class="div-col"> <ul><li>Scientific value</li> <li>Social value</li> <li>Respect for persons</li> <li>Community engagement</li> <li>Concern for participant welfare and interests</li> <li>A balance towards benefit over risks</li> <li>Post-trial access to tested therapies that had been withheld during the trial</li></ul> </div> <div class="mw-heading mw-heading3"><h3 id="Pregnant_women_and_children">Pregnant women and children</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=28" title="Edit section: Pregnant women and children"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">See also: <a href="/wiki/Pregnant_women_in_clinical_research" title="Pregnant women in clinical research">pregnant women in clinical research</a> and <a href="/wiki/Children_in_clinical_research" title="Children in clinical research">Children in clinical research</a></div> <p>Pregnant women and children are typically excluded from clinical trials as vulnerable populations, though the data to support excluding them is not robust. By excluding them from clinical trials, information about the safety and effectiveness of therapies for these populations is often lacking. During the early history of the <a href="/wiki/HIV/AIDS" title="HIV/AIDS">HIV/AIDS</a> epidemic, a scientist noted that by excluding these groups from potentially life-saving treatment, they were being "protected to death". Projects such as Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) have advocated for the ethical inclusion of pregnant women in vaccine trials. Inclusion of children in clinical trials has additional moral considerations, as children lack decision-making autonomy. Trials in the past had been criticized for using hospitalized children or orphans; these ethical concerns effectively stopped future research. In efforts to maintain effective pediatric care, several European countries and the US have policies to entice or compel pharmaceutical companies to conduct pediatric trials. International guidance recommends ethical pediatric trials by limiting harm, considering varied risks, and taking into account the complexities of pediatric care.<sup id="cite_ref-Edwards_87-1" class="reference"><a href="#cite_note-Edwards-87"><span class="cite-bracket">[</span>87<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Safety">Safety</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=29" title="Edit section: Safety"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study, and (in some cases, if the study involves a marketable drug or device), the regulatory agency for the country where the drug or device will be sold. </p><p>A systematic concurrent safety review is frequently employed to assure research participant safety. The conduct and on-going review is designed to be proportional to the risk of the trial. Typically this role is filled by a <a href="/wiki/Data_safety_monitoring_board" class="mw-redirect" title="Data safety monitoring board">Data and Safety Committee</a>, an externally appointed Medical Safety Monitor,<sup id="cite_ref-88" class="reference"><a href="#cite_note-88"><span class="cite-bracket">[</span>88<span class="cite-bracket">]</span></a></sup> an <a href="/wiki/Independent_safety_officer" title="Independent safety officer">Independent Safety Officer</a>, or for small or low-risk studies the principal investigator.<sup id="cite_ref-89" class="reference"><a href="#cite_note-89"><span class="cite-bracket">[</span>89<span class="cite-bracket">]</span></a></sup> </p><p>For safety reasons, many clinical trials of drugs<sup id="cite_ref-90" class="reference"><a href="#cite_note-90"><span class="cite-bracket">[</span>90<span class="cite-bracket">]</span></a></sup> are designed to exclude women of childbearing age, pregnant women, or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures. </p> <div class="mw-heading mw-heading3"><h3 id="Sponsor">Sponsor</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=30" title="Edit section: Sponsor"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment(s) with already approved treatments. This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for <a href="/wiki/Monitoring_in_clinical_trials" title="Monitoring in clinical trials">monitoring</a> the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a <a href="/wiki/Data_monitoring_committee" title="Data monitoring committee">data monitoring committee</a> (DMC, known in the US as a data safety monitoring board). This independent group of clinicians and statisticians meets periodically to review the <a href="/wiki/Blind_experiment" class="mw-redirect" title="Blind experiment">unblinded</a> data the sponsor has received so far. The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious <a href="/wiki/Adverse_event" title="Adverse event">adverse events</a>. The sponsor is responsible for collecting <a href="/wiki/Adverse_event" title="Adverse event">adverse event</a> reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment. </p><p>The sponsor and the local site investigators are jointly responsible for writing a site-specific <a href="/wiki/Informed_consent" title="Informed consent">informed consent</a> that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language. FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time.<sup id="cite_ref-91" class="reference"><a href="#cite_note-91"><span class="cite-bracket">[</span>91<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Local_site_investigators">Local site investigators</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=31" title="Edit section: Local site investigators"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1251242444">.mw-parser-output .ambox{border:1px solid #a2a9b1;border-left:10px solid #36c;background-color:#fbfbfb;box-sizing:border-box}.mw-parser-output .ambox+link+.ambox,.mw-parser-output .ambox+link+style+.ambox,.mw-parser-output .ambox+link+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+style+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+link+.ambox{margin-top:-1px}html body.mediawiki .mw-parser-output .ambox.mbox-small-left{margin:4px 1em 4px 0;overflow:hidden;width:238px;border-collapse:collapse;font-size:88%;line-height:1.25em}.mw-parser-output .ambox-speedy{border-left:10px solid #b32424;background-color:#fee7e6}.mw-parser-output .ambox-delete{border-left:10px solid #b32424}.mw-parser-output .ambox-content{border-left:10px solid #f28500}.mw-parser-output .ambox-style{border-left:10px solid #fc3}.mw-parser-output .ambox-move{border-left:10px solid #9932cc}.mw-parser-output .ambox-protection{border-left:10px solid #a2a9b1}.mw-parser-output .ambox .mbox-text{border:none;padding:0.25em 0.5em;width:100%}.mw-parser-output .ambox .mbox-image{border:none;padding:2px 0 2px 0.5em;text-align:center}.mw-parser-output .ambox .mbox-imageright{border:none;padding:2px 0.5em 2px 0;text-align:center}.mw-parser-output .ambox .mbox-empty-cell{border:none;padding:0;width:1px}.mw-parser-output .ambox .mbox-image-div{width:52px}@media(min-width:720px){.mw-parser-output .ambox{margin:0 10%}}@media print{body.ns-0 .mw-parser-output .ambox{display:none!important}}</style><table class="box-Unreferenced_section plainlinks metadata ambox ambox-content ambox-Unreferenced" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>does not <a href="/wiki/Wikipedia:Citing_sources" title="Wikipedia:Citing sources">cite</a> any <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">sources</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Clinical_trial" title="Special:EditPage/Clinical trial">improve this section</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a>. Unsourced material may be challenged and <a href="/wiki/Wikipedia:Verifiability#Burden_of_evidence" title="Wikipedia:Verifiability">removed</a>.</span> <span class="date-container"><i>(<span class="date">November 2014</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <p>The ethical principle of <i><a href="/wiki/Primum_non-nocere" class="mw-redirect" title="Primum non-nocere">primum non-nocere</a></i> ("first, do no harm") guides the trial, and if an investigator believes the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects, and could act unethically to obtain and maintain their participation. </p><p>The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study. The local investigator or his/her study staff are also responsible for ensuring the potential subjects in the study understand the risks and potential benefits of participating in the study. In other words, they (or their legally authorized representatives) must give truly informed consent. </p><p>Local investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinions of both the investigator (at the site where the adverse event occurred) and the sponsor, regarding the relationship of the adverse event to the study treatments. Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events. </p><p>When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study. </p> <div class="mw-heading mw-heading3"><h3 id="Institutional_review_boards_(IRBs)"><span id="Institutional_review_boards_.28IRBs.29"></span>Institutional review boards (IRBs)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=32" title="Edit section: Institutional review boards (IRBs)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Approval by an <a href="/wiki/Institutional_Review_Board" class="mw-redirect" title="Institutional Review Board">Institutional Review Board</a> (IRB), or <a href="/wiki/Ethics_committee" title="Ethics committee">Independent Ethics Committee</a> (IEC), is necessary before all but the most informal research can begin. In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial. However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent(s), the data collection forms, and supporting documentation to the local IRB. Universities and most hospitals have in-house IRBs. Other researchers (such as in walk-in clinics) use independent IRBs. </p><p>The IRB scrutinizes the study both for medical safety and for protection of the patients involved in the study, before it allows the researcher to begin the study. It may require changes in study procedures or in the explanations given to the patient. A required yearly "continuing review" report from the investigator updates the IRB on the progress of the study and any new safety information related to the study. </p> <div class="mw-heading mw-heading3"><h3 id="Regulatory_agencies">Regulatory agencies</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=33" title="Edit section: Regulatory agencies"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the US, the <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">FDA</a> can <a href="/wiki/Audit" title="Audit">audit</a> the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures. This audit may be random, or for cause (because the investigator is suspected of fraudulent data). Avoiding an audit is an incentive for investigators to follow study procedures. A 'covered clinical study' refers to a trial submitted to the FDA as part of a marketing application (for example, as part of an <a href="/wiki/New_drug_application" class="mw-redirect" title="New drug application">NDA</a> or <a href="/wiki/510(k)" class="mw-redirect" title="510(k)">510(k)</a>), about which the FDA may require disclosure of financial interest of the <a href="/wiki/Clinical_investigator" title="Clinical investigator">clinical investigator</a> in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as "...<span class="nowrap"> </span>any study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or any study in which a single investigator makes a significant contribution to the demonstration of safety."<sup id="cite_ref-92" class="reference"><a href="#cite_note-92"><span class="cite-bracket">[</span>92<span class="cite-bracket">]</span></a></sup> </p><p>Alternatively, many American pharmaceutical companies have moved some clinical trials overseas. Benefits of conducting trials abroad include lower costs (in some countries) and the ability to run larger trials in shorter timeframes, whereas a potential disadvantage exists in lower-quality trial management.<sup id="cite_ref-93" class="reference"><a href="#cite_note-93"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> Different countries have different regulatory requirements and enforcement abilities. An estimated 40% of all clinical trials now take place in Asia, Eastern Europe, and Central and South America. "There is no compulsory registration system for clinical trials in these countries and many do not follow European directives in their operations", says Jacob Sijtsma of the Netherlands-based WEMOS, an advocacy health organisation tracking clinical trials in developing countries.<sup id="cite_ref-94" class="reference"><a href="#cite_note-94"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> </p><p>Beginning in the 1980s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization named after 1990 as the <a href="/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use" class="mw-redirect" title="International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use</a> (ICH)<sup id="cite_ref-95" class="reference"><a href="#cite_note-95"><span class="cite-bracket">[</span>95<span class="cite-bracket">]</span></a></sup> Currently, most clinical trial programs follow ICH guidelines, aimed at "ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness."<sup id="cite_ref-ich_96-0" class="reference"><a href="#cite_note-ich-96"><span class="cite-bracket">[</span>96<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Aggregation_of_safety_data_during_clinical_development">Aggregation of safety data during clinical development</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=34" title="Edit section: Aggregation of safety data during clinical development"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Aggregating safety data across clinical trials during drug development is important because trials are generally designed to focus on determining how well the drug works. The safety data collected and aggregated across multiple trials as the drug is developed allows the sponsor, investigators and regulatory agencies to monitor the aggregate safety profile of experimental medicines as they are developed. The value of assessing aggregate safety data is: a) decisions based on aggregate safety assessment during development of the medicine can be made throughout the medicine's development and b) it sets up the sponsor and regulators well for assessing the medicine's safety after the drug is approved.<sup id="cite_ref-97" class="reference"><a href="#cite_note-97"><span class="cite-bracket">[</span>97<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-98" class="reference"><a href="#cite_note-98"><span class="cite-bracket">[</span>98<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-99" class="reference"><a href="#cite_note-99"><span class="cite-bracket">[</span>99<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-100" class="reference"><a href="#cite_note-100"><span class="cite-bracket">[</span>100<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-101" class="reference"><a href="#cite_note-101"><span class="cite-bracket">[</span>101<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Economics">Economics</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=35" title="Edit section: Economics"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in the United States from 2004 to 2012 found the average cost of Phase<span class="nowrap"> </span>I trials to be between $1.4 million and $6.6 million, depending on the type of disease. Phase II trials ranged from $7 million to $20 million, and Phase<span class="nowrap"> </span>III trials from $11 million to $53 million.<sup id="cite_ref-102" class="reference"><a href="#cite_note-102"><span class="cite-bracket">[</span>102<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Sponsor_2">Sponsor</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=36" title="Edit section: Sponsor"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients involved, and whether the study treatment is already approved for medical use. </p><p>The expenses incurred by a pharmaceutical company in administering a Phase III or<span class="nowrap"> </span>IV clinical trial may include, among others: </p> <ul><li>production of the drug(s) or device(s) being evaluated</li> <li>staff salaries for the designers and administrators of the trial</li> <li>payments to the contract research organization, the site management organization (if used) and any outside consultants</li> <li>payments to local researchers and their staff for their time and effort in recruiting test subjects and collecting data for the sponsor</li> <li>the cost of study materials and the charges incurred to ship them</li> <li>communication with the local researchers, including on-site monitoring by the CRO before and (in some cases) multiple times during the study</li> <li>one or more investigator training meetings</li> <li>expense incurred by the local researchers, such as pharmacy fees, IRB fees and postage</li> <li>any payments to subjects enrolled in the trial</li> <li>the expense of treating a test subject who develops a medical condition caused by the study drug</li></ul> <p>These expenses are incurred over several years. </p><p>In the US, sponsors may receive a 50 percent <a href="/wiki/Tax_credit" title="Tax credit">tax credit</a> for clinical trials conducted on drugs being developed for the treatment of <a href="/wiki/Orphan_disease" class="mw-redirect" title="Orphan disease">orphan diseases</a>.<sup id="cite_ref-103" class="reference"><a href="#cite_note-103"><span class="cite-bracket">[</span>103<span class="cite-bracket">]</span></a></sup> National health agencies, such as the US <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a>, offer grants to investigators who design clinical trials that attempt to answer research questions of interest to the agency. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites. These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them. Using internet resources can, in some cases, reduce the economic burden.<sup id="cite_ref-Paul2005_104-0" class="reference"><a href="#cite_note-Paul2005-104"><span class="cite-bracket">[</span>104<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Investigators">Investigators</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=37" title="Edit section: Investigators"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Investigators are often compensated for their work in clinical trials. These amounts can be small, just covering a partial salary for research assistants and the cost of any supplies (usually the case with national health agency studies), or be substantial and include "overhead" that allows the investigator to pay the research staff during times between clinical trials.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (October 2017)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Subjects">Subjects</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=38" title="Edit section: Subjects"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Participants in Phase I drug trials do not gain any direct health benefit from taking part. They are generally paid a fee for their time, with payments regulated and not related to any risk involved. Motivations of healthy volunteers is not limited to financial reward and may include other motivations such as contributing to science and others.<sup id="cite_ref-105" class="reference"><a href="#cite_note-105"><span class="cite-bracket">[</span>105<span class="cite-bracket">]</span></a></sup> In later phase trials, subjects may not be paid to ensure their motivation for participating with potential for a health benefit or contributing to medical knowledge. Small payments may be made for study-related expenses such as travel or as compensation for their time in providing follow-up information about their health after the trial treatment ends. </p> <div class="mw-heading mw-heading2"><h2 id="Participant_recruitment_and_participation">Participant recruitment and participation</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=39" title="Edit section: Participant recruitment and participation"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure typeof="mw:File/Thumb"><a href="/wiki/File:Clinical_trial_newspaper_advertisements.JPG" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/en/thumb/f/fc/Clinical_trial_newspaper_advertisements.JPG/250px-Clinical_trial_newspaper_advertisements.JPG" decoding="async" width="250" height="187" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/f/fc/Clinical_trial_newspaper_advertisements.JPG 1.5x" data-file-width="365" data-file-height="273" /></a><figcaption><a href="/wiki/Newspaper_advertisement" class="mw-redirect" title="Newspaper advertisement">Newspaper advertisements</a> seeking patients and healthy <a href="/wiki/Volunteering" title="Volunteering">volunteers</a> to participate in clinical trials</figcaption></figure> <p>Phase 0 and Phase I drug trials seek healthy volunteers. Most other clinical trials seek patients who have a specific disease or medical condition. The diversity observed in society should be reflected in clinical trials through the appropriate inclusion of <a href="/wiki/Ethnic_minority" class="mw-redirect" title="Ethnic minority">ethnic minority</a> populations.<sup id="cite_ref-ethnic2011_106-0" class="reference"><a href="#cite_note-ethnic2011-106"><span class="cite-bracket">[</span>106<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Patient_recruitment" title="Patient recruitment">Patient recruitment</a> or participant recruitment plays a significant role in the activities and responsibilities of sites conducting clinical trials.<sup id="cite_ref-107" class="reference"><a href="#cite_note-107"><span class="cite-bracket">[</span>107<span class="cite-bracket">]</span></a></sup> </p><p>All volunteers being considered for a trial are required to undertake a medical screening. Requirements differ according to the trial needs, but typically volunteers would be screened in a <a href="/wiki/Medical_laboratory" title="Medical laboratory">medical laboratory</a> for:<sup id="cite_ref-cw_108-0" class="reference"><a href="#cite_note-cw-108"><span class="cite-bracket">[</span>108<span class="cite-bracket">]</span></a></sup> </p> <ul><li>Measurement of the electrical activity of the heart (ECG)</li> <li>Measurement of blood pressure, heart rate, and body temperature</li> <li>Blood sampling</li> <li>Urine sampling</li> <li>Weight and height measurement</li> <li>Drug abuse testing</li> <li>Pregnancy testing</li></ul> <p>It has been observed that participants in clinical trials are disproportionately white.<sup id="cite_ref-109" class="reference"><a href="#cite_note-109"><span class="cite-bracket">[</span>109<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-110" class="reference"><a href="#cite_note-110"><span class="cite-bracket">[</span>110<span class="cite-bracket">]</span></a></sup> Often, minorities are not informed about clinical trials.<sup id="cite_ref-111" class="reference"><a href="#cite_note-111"><span class="cite-bracket">[</span>111<span class="cite-bracket">]</span></a></sup> One recent systematic review of the literature found that race/ethnicity as well as sex were not well-represented nor at times even tracked as participants in a large number of clinical trials of hearing loss management in adults.<sup id="cite_ref-112" class="reference"><a href="#cite_note-112"><span class="cite-bracket">[</span>112<span class="cite-bracket">]</span></a></sup> This may reduce the validity of findings in respect of non-white patients<sup id="cite_ref-113" class="reference"><a href="#cite_note-113"><span class="cite-bracket">[</span>113<span class="cite-bracket">]</span></a></sup> by not adequately representing the larger population<a href="/wiki/Alzheimer%27s_disease_in_the_Hispanic/Latino_population" title="Alzheimer's disease in the Hispanic/Latino population">s</a>. </p> <div class="mw-heading mw-heading3"><h3 id="Locating_trials">Locating trials</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=40" title="Edit section: Locating trials"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Depending on the kind of participants required, sponsors of clinical trials, or contract research organizations working on their behalf, try to find sites with qualified personnel as well as access to patients who could participate in the trial. Working with those sites, they may use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go (such as doctor's offices), and personal recruitment of patients by investigators. </p><p>Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials. For example, the Fox Trial Finder connects <a href="/wiki/Parkinson%27s_disease" title="Parkinson's disease">Parkinson's disease</a> trials around the world to volunteers who have a specific set of criteria such as location, age, and symptoms.<sup id="cite_ref-114" class="reference"><a href="#cite_note-114"><span class="cite-bracket">[</span>114<span class="cite-bracket">]</span></a></sup> Other disease-specific services exist for volunteers to find trials related to their condition.<sup id="cite_ref-115" class="reference"><a href="#cite_note-115"><span class="cite-bracket">[</span>115<span class="cite-bracket">]</span></a></sup> Volunteers may search directly on <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a> to locate trials using a registry run by the <a href="/wiki/U.S._National_Institutes_of_Health" class="mw-redirect" title="U.S. National Institutes of Health">U.S. National Institutes of Health</a> and <a href="/wiki/National_Library_of_Medicine" class="mw-redirect" title="National Library of Medicine">National Library of Medicine</a>. There also is software that allows clinicians to find trial options for an individual patient based on data such as genomic data.<sup id="cite_ref-116" class="reference"><a href="#cite_note-116"><span class="cite-bracket">[</span>116<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Research">Research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=41" title="Edit section: Research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Eli_Lilly_clinical_trials_booth.jpg" class="mw-file-description"><img alt="Eli Lilly booths" src="//upload.wikimedia.org/wikipedia/commons/thumb/8/8e/Eli_Lilly_clinical_trials_booth.jpg/220px-Eli_Lilly_clinical_trials_booth.jpg" decoding="async" width="220" height="165" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/8e/Eli_Lilly_clinical_trials_booth.jpg/330px-Eli_Lilly_clinical_trials_booth.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/8/8e/Eli_Lilly_clinical_trials_booth.jpg/440px-Eli_Lilly_clinical_trials_booth.jpg 2x" data-file-width="4032" data-file-height="3024" /></a><figcaption>Eli Lilly pharmaceutical company recruiting participants at the Indiana State Fair</figcaption></figure> <p>The risk information seeking and processing (RISP) model analyzes social implications that affect attitudes and decision making pertaining to clinical trials.<sup id="cite_ref-yang_117-0" class="reference"><a href="#cite_note-yang-117"><span class="cite-bracket">[</span>117<span class="cite-bracket">]</span></a></sup> People who hold a higher stake or interest in the treatment provided in a clinical trial showed a greater likelihood of seeking information about clinical trials. Cancer patients reported more optimistic attitudes towards clinical trials than the general population. Having a more optimistic outlook on clinical trials also leads to greater likelihood of enrolling.<sup id="cite_ref-yang_117-1" class="reference"><a href="#cite_note-yang-117"><span class="cite-bracket">[</span>117<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Matching">Matching</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=42" title="Edit section: Matching"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Matching involves a systematic comparison of a patient's clinical and demographic information against the eligibility criteria of various trials. Methods include: </p> <ul><li>Manual: Healthcare providers or clinical trial coordinators manually review patient records and available trial criteria to identify potential matches.<sup id="cite_ref-cancer.net_118-0" class="reference"><a href="#cite_note-cancer.net-118"><span class="cite-bracket">[</span>118<span class="cite-bracket">]</span></a></sup> This might also include manually searching in clinical trial databases.<sup id="cite_ref-ctg_119-0" class="reference"><a href="#cite_note-ctg-119"><span class="cite-bracket">[</span>119<span class="cite-bracket">]</span></a></sup></li> <li><a href="/wiki/Electronic_health_record" title="Electronic health record">Electronic health records</a> (EHR). Some systems integrate with EHRs to automatically flag patients that may be eligible for trials based on their medical data. These systems may leverage <a href="/wiki/Machine_learning" title="Machine learning">machine learning</a>, <a href="/wiki/Artificial_intelligence" title="Artificial intelligence">artificial intelligence</a> or <a href="/wiki/Precision_medicine" class="mw-redirect" title="Precision medicine">precision medicine</a> methods to more effectively match patients to trials.<sup id="cite_ref-fount_120-0" class="reference"><a href="#cite_note-fount-120"><span class="cite-bracket">[</span>120<span class="cite-bracket">]</span></a></sup> These methods are faced with the challenge of overcoming the limitations of EHR records such as omissions and logging errors.</li> <li>Direct-to-patient services: Resources are specialized to support patients in finding clinical trials through online platforms, hotlines, and personalized support.<sup id="cite_ref-cancer.net_118-1" class="reference"><a href="#cite_note-cancer.net-118"><span class="cite-bracket">[</span>118<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-ctg_119-1" class="reference"><a href="#cite_note-ctg-119"><span class="cite-bracket">[</span>119<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-121" class="reference"><a href="#cite_note-121"><span class="cite-bracket">[</span>121<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading2"><h2 id="Decentralized_trials">Decentralized trials</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=43" title="Edit section: Decentralized trials"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Although trials are commonly conducted at major medical centers, some participants are excluded due to the distance and expenses required for travel, leading to hardship, disadvantage, and inequity for participants, especially those in rural and underserved communities. Therefore, the concept of a "decentralized clinical trial" that minimizes or eliminates the need for patients to travel to sites,<sup id="cite_ref-122" class="reference"><a href="#cite_note-122"><span class="cite-bracket">[</span>122<span class="cite-bracket">]</span></a></sup> is now more widespread, a capability improved by <a href="/wiki/Telehealth" title="Telehealth">telehealth</a> and <a href="/wiki/Wearable_technology" title="Wearable technology">wearable technologies</a>.<sup id="cite_ref-123" class="reference"><a href="#cite_note-123"><span class="cite-bracket">[</span>123<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=44" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/Outcome_measure" title="Outcome measure">Outcome measure</a></li> <li><a href="/wiki/Odds_algorithm" title="Odds algorithm">Odds algorithm</a></li> <li><a href="/wiki/Preregistration_(science)" title="Preregistration (science)">Preregistration (science)</a></li> <li><a href="/wiki/Marketing_authorisation" title="Marketing authorisation">Marketing authorisation</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_trial&action=edit&section=45" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output 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<span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics">"NIH Clinical Research Trials and You: The Basics"</a>. US National Institutes of Health. 3 October 2022. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20200422043900/https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics">Archived</a> from the original on 22 April 2020<span class="reference-accessdate">. Retrieved <span class="nowrap">7 November</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=NIH+Clinical+Research+Trials+and+You%3A+The+Basics&rft.pub=US+National+Institutes+of+Health&rft.date=2022-10-03&rft_id=https%3A%2F%2Fwww.nih.gov%2Fhealth-information%2Fnih-clinical-research-trials-you%2Fbasics&rfr_id=info%3Asid%2Fen.wikipedia.org%3AClinical+trial" class="Z3988"></span></span> </li> <li id="cite_note-gates-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-gates_2-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://docs.gatesfoundation.org/documents/clinical_trials.pdf">"Clinical Trials"</a> <span class="cs1-format">(PDF)</span>. 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Retrieved <span class="nowrap">26 February</span> 2017</span>. <q>Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval.<span class="nowrap"> </span>...</q></cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=The+New+York+Times&rft.atitle=The+Solution+to+Drug+Prices&rft.date=2015-09-09&rft.aulast=Emanuel&rft.aufirst=Ezekiel+J.&rft_id=https%3A%2F%2Fwww.nytimes.com%2F2015%2F09%2F09%2Fopinion%2Fthe-solution-to-drug-prices.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AClinical+trial" class="Z3988"></span></span> </li> <li id="cite_note-7"><span class="mw-cite-backlink"><b><a href="#cite_ref-7">^</a></b></span> <span class="reference-text">FDA Page last updated 25 April 2014 <a rel="nofollow" class="external text" href="https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm">FDA's Drug Review Process: Continued</a> <a rel="nofollow" class="external text" href="https://web.archive.org/web/20190423192717/https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm">Archived</a> 23 April 2019 at the <a href="/wiki/Wayback_Machine" title="Wayback Machine">Wayback Machine</a></span> </li> <li id="cite_note-8"><span class="mw-cite-backlink"><b><a href="#cite_ref-8">^</a></b></span> <span class="reference-text">PhRMA. 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Retrieved <span class="nowrap">24 May</span> 2019</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=What+are+the+different+types+of+clinical+research%3F&rft.pub=US+Food+and+Drug+Administration&rft.date=2019&rft_id=https%3A%2F%2Fwww.fda.gov%2Fpatients%2Fclinical-trials-what-patients-need-know%2Fwhat-are-different-types-clinical-research&rfr_id=info%3Asid%2Fen.wikipedia.org%3AClinical+trial" class="Z3988"></span></span> </li> <li id="cite_note-reg-auth-13"><span class="mw-cite-backlink"><b><a href="#cite_ref-reg-auth_13-0">^</a></b></span> <span class="reference-text">The regulatory authority in the US is the <a href="/wiki/Food_and_Drug_Administration_(United_States)" class="mw-redirect" title="Food and Drug Administration (United States)">Food and Drug Administration</a>; in Canada, <a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a>; in the <a href="/wiki/European_Union" title="European Union">European Union</a>, the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a>; and in Japan, the <a href="/wiki/Ministry_of_Health,_Labour_and_Welfare_(Japan)" class="mw-redirect" title="Ministry of Health, Labour and Welfare (Japan)">Ministry of Health, Labour and Welfare</a></span> </li> <li id="cite_note-14"><span class="mw-cite-backlink"><b><a href="#cite_ref-14">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050419.htm">"Medical Devices, Premarket Clinical Studies for Investigational Device Exemption"</a>. 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Public Health</i>. <b>10</b>. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://doi.org/10.3389%2Ffpubh.2022.1081150">10.3389/fpubh.2022.1081150</a></span>. <a href="/wiki/PMC_(identifier)" class="mw-redirect" title="PMC (identifier)">PMC</a> <span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9797802">9797802</a></span>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a> <a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/36590004">36590004</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Front.+Public+Health&rft.atitle=Decentralized+clinical+trials+%28DCTs%29%3A+A+few+ethical+considerations&rft.volume=10&rft.date=2022-12-15&rft_id=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC9797802%23id-name%3DPMC&rft_id=info%3Apmid%2F36590004&rft_id=info%3Adoi%2F10.3389%2Ffpubh.2022.1081150&rft.aulast=Petrini&rft.aufirst=Carlo&rft_id=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC9797802&rfr_id=info%3Asid%2Fen.wikipedia.org%3AClinical+trial" class="Z3988"></span></span> </li> <li id="cite_note-123"><span class="mw-cite-backlink"><b><a href="#cite_ref-123">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFVan_Norman2021" class="citation journal cs1">Van Norman, G. 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clinical trial</a></li></ul></li> <li><a href="/wiki/Academic_clinical_trials" class="mw-redirect" title="Academic clinical trials">Academic clinical trials</a></li> <li><a href="/wiki/Clinical_study_design" title="Clinical study design">Clinical study design</a></li> <li><a href="/wiki/Evidence-based_medicine" title="Evidence-based medicine">Evidence-based medicine</a></li> <li><a href="/wiki/Real_world_evidence" title="Real world evidence">Real world evidence</a></li> <li><a href="/wiki/Patient_and_public_involvement" title="Patient and public involvement">Patient and public involvement</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Scientific_control" title="Scientific control">Controlled study</a><br />(<a href="/wiki/Hierarchy_of_evidence#USA" title="Hierarchy of evidence">EBM I to II-1</a>)</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Randomized_controlled_trial" title="Randomized controlled trial">Randomized controlled trial</a> <ul><li><a href="/wiki/Experiment" title="Experiment">Scientific experiment</a></li> <li><a href="/wiki/Blind_experiment" class="mw-redirect" title="Blind experiment">Blind experiment</a></li> <li><a href="/wiki/Open-label_trial" title="Open-label trial">Open-label trial</a></li></ul></li> <li><a href="/wiki/Adaptive_clinical_trial" class="mw-redirect" title="Adaptive clinical trial">Adaptive clinical trial</a> <ul><li><a href="/wiki/Platform_trial" title="Platform trial">Platform trial</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Observational_study" title="Observational study">Observational study</a><br />(<a href="/wiki/Hierarchy_of_evidence#USA" title="Hierarchy of evidence">EBM II-2 to II-3</a>)</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Cross-sectional_study" title="Cross-sectional study">Cross-sectional study</a> vs. <a href="/wiki/Longitudinal_study" title="Longitudinal study">Longitudinal study</a>, <a href="/wiki/Ecological_study" title="Ecological study">Ecological study</a></li> <li><a href="/wiki/Cohort_study" title="Cohort study">Cohort study</a> <ul><li><a href="/wiki/Retrospective_cohort_study" title="Retrospective cohort study">Retrospective</a></li> <li><a href="/wiki/Prospective_cohort_study" title="Prospective cohort study">Prospective</a></li></ul></li> <li><a href="/wiki/Case%E2%80%93control_study" title="Case–control study">Case–control study</a> (<a href="/wiki/Nested_case%E2%80%93control_study" title="Nested case–control study">Nested case–control study</a>)</li> <li><a href="/wiki/Case_series" title="Case series">Case series</a></li> <li><a href="/wiki/Case_study" title="Case study">Case study</a></li> <li><a href="/wiki/Case_report" title="Case report">Case report</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Outcome_measure" title="Outcome measure">Measures</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Measures_of_occurrence" class="mw-redirect" title="Epidemiological methods">Occurrence</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Incidence_(epidemiology)" title="Incidence (epidemiology)">Incidence</a>, <a href="/wiki/Cumulative_incidence" class="mw-redirect" title="Cumulative incidence">Cumulative incidence</a>, <a href="/wiki/Prevalence" title="Prevalence">Prevalence</a>, <a href="/wiki/Point_prevalence" class="mw-redirect" title="Point prevalence">Point prevalence</a>, <a href="/wiki/Period_prevalence" class="mw-redirect" title="Period prevalence">Period prevalence</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Measures_of_association" class="mw-redirect" title="Epidemiological methods">Association</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Risk_difference" title="Risk difference">Risk difference</a>, <a href="/wiki/Number_needed_to_treat" title="Number needed to treat">Number needed to treat</a>, <a href="/wiki/Number_needed_to_harm" title="Number needed to harm">Number needed to harm</a>, <a href="/wiki/Risk_ratio" class="mw-redirect" title="Risk ratio">Risk ratio</a>, <a href="/wiki/Relative_risk_reduction" title="Relative risk reduction">Relative risk reduction</a>, <a href="/wiki/Odds_ratio" title="Odds ratio">Odds ratio</a>, <a href="/wiki/Hazard_ratio" title="Hazard ratio">Hazard ratio</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Population_impact_measure" title="Population impact measure">Population impact</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Attributable_fraction_among_the_exposed" title="Attributable fraction among the exposed">Attributable fraction among the exposed</a>, <a href="/wiki/Attributable_fraction_for_the_population" title="Attributable fraction for the population">Attributable fraction for the population</a>, <a href="/wiki/Preventable_fraction_among_the_unexposed" title="Preventable fraction among the unexposed">Preventable fraction among the unexposed</a>, <a href="/wiki/Preventable_fraction_for_the_population" title="Preventable fraction for the population">Preventable fraction for the population</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Other_measures" class="mw-redirect" title="Epidemiological methods">Other</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Clinical_endpoint" title="Clinical endpoint">Clinical endpoint</a>, <a href="/wiki/Virulence" title="Virulence">Virulence</a>, <a href="/wiki/Infectivity" title="Infectivity">Infectivity</a>, <a href="/wiki/Mortality_rate" title="Mortality rate">Mortality rate</a>, <a href="/wiki/Morbidity" class="mw-redirect" title="Morbidity">Morbidity</a>, <a href="/wiki/Case_fatality_rate" title="Case fatality rate">Case fatality rate</a>, <a href="/wiki/Specificity_and_sensitivity" class="mw-redirect" title="Specificity and sensitivity">Specificity and sensitivity</a>, <a href="/wiki/Likelihood_ratios_in_diagnostic_testing" title="Likelihood ratios in diagnostic testing">Likelihood-ratios</a>, <a href="/wiki/Pre-_and_post-test_probability" title="Pre- and post-test probability">Pre- and post-test probability</a></div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Trial/test types</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/In_vitro" title="In vitro">In vitro</a></li> <li><a href="/wiki/In_vivo" title="In vivo">In vivo</a></li> <li><a href="/wiki/Animal_testing" title="Animal testing">Animal testing</a></li> <li><a href="/wiki/Animal_testing_on_non-human_primates" title="Animal testing on non-human primates">Animal testing on non-human primates</a></li> <li><a href="/wiki/First-in-man_study" class="mw-redirect" title="First-in-man study">First-in-man study</a></li> <li><a href="/wiki/Multicenter_trial" title="Multicenter trial">Multicenter trial</a></li> <li><a href="/wiki/Seeding_trial" title="Seeding trial">Seeding trial</a></li> <li><a href="/wiki/Vaccine_trial" title="Vaccine trial">Vaccine trial</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Analysis_of_clinical_trials" title="Analysis of clinical trials">Analysis of clinical trials</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Risk%E2%80%93benefit_ratio" title="Risk–benefit ratio">Risk–benefit ratio</a></li> <li><a href="/wiki/Systematic_review" title="Systematic review">Systematic review</a></li> <li><a href="/wiki/Reproducibility" title="Reproducibility">Replication</a></li> <li><a href="/wiki/Meta-analysis" title="Meta-analysis">Meta-analysis</a></li> <li><a href="/wiki/Intention-to-treat_analysis" title="Intention-to-treat analysis">Intention-to-treat analysis</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Interpretation of results</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Selection_bias" title="Selection bias">Selection bias</a></li> <li><a href="/wiki/Survivorship_bias" title="Survivorship bias">Survivorship bias</a></li> <li><a href="/wiki/Correlation_does_not_imply_causation" title="Correlation does not imply causation">Correlation does not imply causation</a></li> <li><a href="/wiki/Null_result" title="Null result">Null result</a></li> <li><a href="/wiki/Sex_as_a_biological_variable" title="Sex as a biological variable">Sex as a biological variable</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div> <ul><li><b><a href="/wiki/Category:Clinical_research" title="Category:Clinical research">Category</a></b></li> <li><b><a href="/wiki/Glossary_of_clinical_research" title="Glossary of clinical research">Glossary</a></b></li> <li><b><a href="/wiki/List_of_clinical_research_topics" class="mw-redirect" title="List of clinical research topics">List of topics</a></b></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="Product_testing" style="padding:3px"><table class="nowraplinks mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Product_testing" title="Template:Product testing"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Product_testing" title="Template talk:Product testing"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Product_testing" title="Special:EditPage/Template:Product testing"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Product_testing" style="font-size:114%;margin:0 4em"><a href="/wiki/Product_testing" title="Product testing">Product testing</a></div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%">Testing organizations</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Standards_organization" title="Standards organization">Standards organization</a></li> <li><a href="/wiki/Consumer_organization" title="Consumer organization">Consumer organization</a></li> <li><a href="/wiki/Trade_organization" class="mw-redirect" title="Trade organization">Trade organization</a></li> <li><a href="/wiki/List_of_food_safety_organisations" title="List of food safety organisations">Food safety organization</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Methodologies</th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Conformance_testing" title="Conformance testing">Conformance testing</a></li> <li><a href="/wiki/Chemical_test" title="Chemical test">Chemical test</a></li> <li><a href="/wiki/Destructive_testing" title="Destructive testing">Destructive testing</a></li> <li><a href="/wiki/Discrimination_testing" title="Discrimination testing">Discrimination testing</a></li> <li><a href="/wiki/Nondestructive_testing" title="Nondestructive testing">Nondestructive testing</a></li> <li><a href="/wiki/Physical_test" title="Physical test">Physical test</a></li> <li><a href="/wiki/Sensory_analysis" title="Sensory analysis">Sensory analysis</a></li> <li><a href="/wiki/Survey_research" class="mw-redirect" title="Survey research">Survey research</a></li> <li><a href="/wiki/Test_method" title="Test method">Test method</a></li> <li><a href="/wiki/Usability_testing" title="Usability testing">Usability testing</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Product fields</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Cannabis_product_testing" title="Cannabis product testing">Cannabis testing</a></li> <li><a href="/wiki/Coffee_cupping" title="Coffee cupping">Coffee cupping</a></li> <li><a href="/wiki/Crash_test" title="Crash test">Crash test</a></li> <li><a class="mw-selflink selflink">Clinical trial</a></li> <li><a href="/wiki/Package_testing" title="Package testing">Package testing</a></li> <li><a href="/wiki/Software_testing" title="Software testing">Software testing</a></li> <li><a href="/wiki/Whisky_tasting" title="Whisky tasting">Whisky tasting</a></li> <li><a href="/wiki/Wine_tasting" title="Wine tasting">Wine tasting</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Scales</th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Hedonic_scale" title="Hedonic scale">Hedonic</a></li> <li><a href="/wiki/Just-About-Right_scale" title="Just-About-Right scale">Just-About-Right</a> (JAR)</li> <li><a href="/wiki/Likert_scale" title="Likert scale">Likert</a></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"></div><div role="navigation" class="navbox" aria-labelledby="Artificial_induction_of_immunity_/_Immunization:_Vaccines,_Vaccination,_Infection,_Inoculation_(J07)" style="padding:3px"><table class="nowraplinks hlist mw-collapsible mw-collapsed navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Vaccines" title="Template:Vaccines"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Vaccines" title="Template talk:Vaccines"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Vaccines" title="Special:EditPage/Template:Vaccines"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Artificial_induction_of_immunity_/_Immunization:_Vaccines,_Vaccination,_Infection,_Inoculation_(J07)" style="font-size:114%;margin:0 4em"><a href="/wiki/Artificial_induction_of_immunity" title="Artificial induction of immunity">Artificial induction of immunity</a> / <a href="/wiki/Immunization" title="Immunization">Immunization</a>: <a href="/wiki/Vaccine" title="Vaccine">Vaccines</a>, <a href="/wiki/Vaccination" title="Vaccination">Vaccination</a>, <a href="/wiki/Infection" title="Infection">Infection</a>, <a href="/wiki/Inoculation" title="Inoculation">Inoculation</a> (<a href="/wiki/ATC_code_J07" title="ATC code J07">J07</a>)</div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%">Development</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Immunologic_adjuvant" title="Immunologic adjuvant">Adjuvants</a></li> <li><a href="/wiki/Vaccine_ingredients" title="Vaccine ingredients">Vaccine ingredients</a> <ul><li><a href="/wiki/List_of_vaccine_excipients" title="List of vaccine excipients">list</a></li></ul></li> <li><a href="/wiki/Mathematical_modelling_of_infectious_diseases" title="Mathematical modelling of infectious diseases">Mathematical modelling</a></li> <li><a href="/wiki/Vaccine_storage" title="Vaccine storage">Storage</a></li> <li><a href="/wiki/Timeline_of_human_vaccines" title="Timeline of human vaccines">Timeline</a></li> <li><a href="/wiki/Vaccine_trial" title="Vaccine trial">Trials</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Classes</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Conjugate_vaccine" title="Conjugate vaccine">Conjugate</a></li> <li><a href="/wiki/Inactivated_vaccine" title="Inactivated vaccine">Inactivated</a></li> <li>Live <ul><li><a href="/wiki/Attenuated_vaccine" title="Attenuated vaccine">Attenuated</a></li> <li><a href="/wiki/Heterologous_vaccine" title="Heterologous vaccine">Heterologous</a></li></ul></li> <li><a href="/wiki/Subunit_vaccine" title="Subunit vaccine">Subunit/component</a> / <a href="/wiki/Peptide_vaccine" title="Peptide vaccine">Peptide</a> / <a href="/wiki/Virus-like_particle" title="Virus-like particle">Virus-like particle</a> / <a href="/wiki/Synthetic_vaccine" title="Synthetic vaccine">Synthetic</a></li> <li><a href="/wiki/DNA_vaccine" title="DNA vaccine">DNA</a> / <a href="/wiki/MRNA_vaccine" title="MRNA vaccine">mRNA</a></li> <li><a href="/wiki/Therapeutic_vaccines" title="Therapeutic vaccines">Therapeutic</a></li> <li><a href="/wiki/Toxoid" title="Toxoid">Toxoid</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Administration</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li>Global: <ul><li><a href="/wiki/GAVI" title="GAVI">GAVI Alliance</a></li> <li><a href="/wiki/National_Immunization_Technical_Advisory_Group" title="National Immunization Technical Advisory Group">NITAG</a></li> <li><a href="/wiki/Strategic_Advisory_Group_of_Experts" title="Strategic Advisory Group of Experts">SAGE</a></li> <li><a href="/wiki/Vaccine_wastage" title="Vaccine wastage">Vaccine wastage</a></li> <li><a href="/wiki/Vaccination_policy" title="Vaccination policy">Policy</a></li> <li><a href="/wiki/Vaccination_schedule" title="Vaccination schedule">Schedule</a></li> <li><a href="/wiki/Vaccine_adverse_event" title="Vaccine adverse event">Vaccine injury</a></li></ul></li> <li>US: <ul><li><a href="/wiki/Advisory_Committee_on_Immunization_Practices" title="Advisory Committee on Immunization Practices">ACIP</a></li> <li><a href="/wiki/National_Vaccine_Injury_Compensation_Program" title="National Vaccine Injury Compensation Program">Vaccine court</a></li> <li><a href="/wiki/Vaccines_for_Children_Program" title="Vaccines for Children Program">Vaccines for Children Program</a></li> <li><a href="/wiki/Vaccine_Adverse_Event_Reporting_System" title="Vaccine Adverse Event Reporting System">VAERS</a></li> <li><a href="/wiki/Vaccine_Safety_Datalink" title="Vaccine Safety Datalink">VSD</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Vaccines</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Bacterial</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Anthrax_vaccine" title="Anthrax vaccine">Anthrax</a></li> <li><a href="/wiki/Brucellosis_vaccine" title="Brucellosis vaccine">Brucellosis</a></li> <li><a href="/wiki/Cholera_vaccine" title="Cholera vaccine">Cholera</a><sup>#</sup></li> <li><a href="/wiki/Diphtheria_vaccine" title="Diphtheria vaccine">Diphtheria</a><sup>#</sup></li> <li><a href="/wiki/Hib_vaccine" title="Hib vaccine">Hib</a><sup>#</sup></li> <li><a href="/wiki/Leptospirosis#Prevention" title="Leptospirosis">Leptospirosis</a></li> <li><a href="/wiki/Lyme_disease#Vaccination" title="Lyme disease">Lyme disease</a><sup>‡</sup></li> <li><a href="/wiki/Meningococcal_vaccine" title="Meningococcal vaccine">Meningococcus</a><sup>#</sup> <ul><li><a href="/wiki/MeNZB" title="MeNZB">MeNZB</a></li> <li><a href="/wiki/NmVac4-A/C/Y/W-135" title="NmVac4-A/C/Y/W-135">NmVac4-A/C/Y/W-135</a></li></ul></li> <li><a href="/wiki/Pertussis_vaccine" title="Pertussis vaccine">Pertussis</a><sup>#</sup></li> <li><a href="/wiki/Plague_vaccine" title="Plague vaccine">Plague</a></li> <li><a href="/wiki/Pneumococcal_vaccine" title="Pneumococcal vaccine">Pneumococcal</a><sup>#</sup> <ul><li><a href="/wiki/Pneumococcal_conjugate_vaccine" title="Pneumococcal conjugate vaccine">PCV</a></li> <li><a href="/wiki/Pneumococcal_polysaccharide_vaccine" title="Pneumococcal polysaccharide vaccine">PPSV</a></li></ul></li> <li><a href="/wiki/Q_fever#Prevention" title="Q fever">Q fever</a></li> <li><a href="/wiki/Tetanus_vaccine" title="Tetanus vaccine">Tetanus</a><sup>#</sup></li> <li><a href="/wiki/Tuberculosis_vaccines" title="Tuberculosis vaccines">Tuberculosis</a> <ul><li><a href="/wiki/BCG_vaccine" title="BCG vaccine">BCG</a><sup>#</sup></li></ul></li> <li><a href="/wiki/Typhoid_vaccine" title="Typhoid vaccine">Typhoid</a><sup>#</sup> <ul><li><a href="/wiki/Ty21a" title="Ty21a">Ty21a</a></li> <li><a href="/wiki/Vi_capsular_polysaccharide_vaccine" title="Vi capsular polysaccharide vaccine">ViCPS</a></li></ul></li> <li><a href="/wiki/Typhus_vaccine" title="Typhus vaccine">Typhus</a></li> <li>combination: <ul><li><a href="/wiki/DPT_vaccine" title="DPT vaccine">DPT/DTwP/DTaP</a></li> <li><a href="/wiki/Tetanus_vaccine" title="Tetanus vaccine">Td/Tdap</a></li></ul></li> <li>research: <ul><li><a href="/wiki/Clostridioides_difficile_infection#Research" title="Clostridioides difficile infection">Clostridioides difficile</a></li> <li><a href="/wiki/Group_B_streptococcal_infection#Vaccine" title="Group B streptococcal infection">Group B streptococcal disease</a></li> <li><a href="/wiki/Shigellosis#Vaccine" title="Shigellosis">Shigellosis</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Viral</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Adenovirus_vaccine" title="Adenovirus vaccine">Adenovirus</a></li> <li><a href="/wiki/Chikungunya_vaccine" title="Chikungunya vaccine">Chikungunya</a></li> <li><a href="/wiki/Ebola_vaccine" title="Ebola vaccine">Ebola</a> <ul><li><a href="/wiki/RVSV-ZEBOV_vaccine" title="RVSV-ZEBOV vaccine">rVSV-ZEBOV</a></li></ul></li> <li><a href="/wiki/Influenza_vaccine" title="Influenza vaccine">Flu</a><sup>#</sup> <ul><li><a href="/wiki/2009_swine_flu_pandemic_vaccine" title="2009 swine flu pandemic vaccine">H1N1</a> (<a href="/wiki/Pandemrix" title="Pandemrix">Pandemrix</a>)</li> <li><a href="/wiki/H5N1_vaccine" title="H5N1 vaccine">H5N1</a></li> <li><a href="/wiki/H5N8_vaccine" title="H5N8 vaccine">H5N8</a></li> <li><a href="/wiki/Live_attenuated_influenza_vaccine" title="Live attenuated influenza vaccine">LAIV</a></li></ul></li> <li><a href="/wiki/Hantavirus_vaccine" title="Hantavirus vaccine">Hantavirus</a></li> <li><a href="/wiki/Hepatitis_A_vaccine" title="Hepatitis A vaccine">Hepatitis A</a><sup>#</sup></li> <li><a href="/wiki/Hepatitis_B_vaccine" title="Hepatitis B vaccine">Hepatitis B</a><sup>#</sup></li> <li><a href="/wiki/Hepatitis_E#Vaccines" title="Hepatitis E">Hepatitis E</a></li> <li><a href="/wiki/HPV_vaccine" title="HPV vaccine">HPV</a><sup>#</sup> <ul><li><a href="/wiki/Cervarix" title="Cervarix">Cervarix</a></li> <li><a href="/wiki/Gardasil" title="Gardasil">Gardasil</a></li></ul></li> <li><a href="/wiki/Japanese_encephalitis_vaccine" title="Japanese encephalitis vaccine">Japanese encephalitis</a><sup>#</sup></li> <li><a href="/wiki/Measles_vaccine" title="Measles vaccine">Measles</a><sup>#</sup></li> <li><a href="/wiki/Mpox_vaccine" class="mw-redirect" title="Mpox vaccine">Mpox</a></li> <li><a href="/wiki/Mumps_vaccine" title="Mumps vaccine">Mumps</a><sup>#</sup></li> <li><a href="/wiki/Polio_vaccine" title="Polio vaccine">Polio</a><sup>#</sup> <ul><li><a href="/wiki/Polio_vaccine#Attenuated" title="Polio vaccine">Sabin</a></li> <li><a href="/wiki/Polio_vaccine#Inactivated" title="Polio vaccine">Salk</a></li></ul></li> <li><a href="/wiki/Rabies_vaccine" title="Rabies vaccine">Rabies</a><sup>#</sup></li> <li><a href="/wiki/Rotavirus_vaccine" title="Rotavirus vaccine">Rotavirus</a><sup>#</sup></li> <li><a href="/wiki/Rubella_vaccine" title="Rubella vaccine">Rubella</a><sup>#</sup></li> <li><a href="/wiki/COVID-19_vaccine" title="COVID-19 vaccine">SARS-CoV-2</a> <ul><li><a href="/wiki/Corbevax" title="Corbevax">Corbevax</a><sup>†</sup></li> <li><a href="/wiki/Covaxin" title="Covaxin">Bharat Biotech</a><sup>†</sup></li> <li><a href="/wiki/Convidecia" title="Convidecia">CanSino</a><sup>†</sup></li> <li><a href="/wiki/CoronaVac" title="CoronaVac">CoronaVac</a><sup>†</sup></li> <li><a href="/wiki/EpiVacCorona" title="EpiVacCorona">EpiVacCorona</a><sup>†</sup></li> <li><a href="/wiki/Janssen_COVID-19_vaccine" title="Janssen COVID-19 vaccine">Janssen</a></li> <li><a href="/wiki/Moderna_COVID-19_vaccine" title="Moderna COVID-19 vaccine">Moderna</a></li> <li><a href="/wiki/Novavax_COVID-19_vaccine" title="Novavax COVID-19 vaccine">Novavax</a></li> <li><a href="/wiki/Oxford%E2%80%93AstraZeneca_COVID-19_vaccine" title="Oxford–AstraZeneca COVID-19 vaccine">Oxford–AstraZeneca</a></li> <li><a href="/wiki/Pfizer%E2%80%93BioNTech_COVID-19_vaccine" title="Pfizer–BioNTech COVID-19 vaccine">Pfizer–BioNTech</a></li> <li><a href="/wiki/Sanofi%E2%80%93GSK_COVID-19_vaccine" title="Sanofi–GSK COVID-19 vaccine">Sanofi–GSK</a><sup>†</sup></li> <li><a href="/wiki/Sinopharm_BIBP_COVID-19_vaccine" title="Sinopharm BIBP COVID-19 vaccine">Sinopharm BIBP</a><sup>†</sup></li> <li><a href="/wiki/Skycovione" title="Skycovione">Skycovione</a><sup>†</sup></li> <li><a href="/wiki/Sputnik_V_COVID-19_vaccine" title="Sputnik V COVID-19 vaccine">Sputnik V</a><sup>†</sup></li> <li><a href="/wiki/Valneva_COVID-19_vaccine" title="Valneva COVID-19 vaccine">Valneva</a><sup>†</sup></li></ul></li> <li><a href="/wiki/Respiratory_syncytial_virus_vaccine" title="Respiratory syncytial virus vaccine">Respiratory syncytial virus (RSV)</a></li> <li><a href="/wiki/Smallpox_vaccine" title="Smallpox vaccine">Smallpox</a></li> <li><a href="/wiki/Tick-borne_encephalitis_vaccine" title="Tick-borne encephalitis vaccine">Tick-borne encephalitis</a><sup>#</sup></li> <li>Varicella zoster <ul><li><a href="/wiki/Varicella_vaccine" title="Varicella vaccine">Chicken pox</a><sup>#</sup></li> <li><a href="/wiki/Zoster_vaccine" title="Zoster vaccine">Shingles</a></li></ul></li> <li><a href="/wiki/Yellow_fever_vaccine" title="Yellow fever vaccine">Yellow fever</a><sup>#</sup></li> <li>combination: <ul><li><a href="/wiki/Hepatitis_A_and_B_vaccine" title="Hepatitis A and B vaccine">Hepatitis A and B</a></li> <li><a href="/wiki/MMR_vaccine" title="MMR vaccine">MMR</a></li> <li><a href="/wiki/MMRV_vaccine" title="MMRV vaccine">MMRV</a></li></ul></li> <li>research: <ul><li><a href="/wiki/Cytomegalovirus_vaccine" title="Cytomegalovirus vaccine">Cytomegalovirus</a></li> <li><a href="/wiki/Dengue_vaccine" title="Dengue vaccine">Dengue</a><sup>#</sup></li> <li><a href="/wiki/Epstein%E2%80%93Barr_virus_vaccine" title="Epstein–Barr virus vaccine">Epstein–Barr virus</a></li> <li><a href="/wiki/Hepatitis_C_vaccine" title="Hepatitis C vaccine">Hepatitis C</a></li> <li><a href="/wiki/Herpes_simplex_research" title="Herpes simplex research">Herpes simplex</a></li> <li><a href="/wiki/HIV_vaccine_development" title="HIV vaccine development">HIV</a></li> <li><a href="/wiki/Zika_virus_vaccine" title="Zika virus vaccine">Zika</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Protozoan</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Malaria_vaccine" title="Malaria vaccine">Malaria</a> <ul><li><a href="/wiki/RTS,S" title="RTS,S">RTS,S</a></li></ul></li> <li>research: <ul><li><a href="/wiki/Trypanosomiasis_vaccine" title="Trypanosomiasis vaccine">Trypanosomiasis</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Helminthiasis" title="Helminthiasis">Helminthiasis</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li>research: <ul><li><a href="/wiki/Hookworm_vaccine" title="Hookworm vaccine">Hookworm</a></li> <li><a href="/wiki/Schistosomiasis_vaccine" title="Schistosomiasis vaccine">Schistosomiasis</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Other</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Androvax" title="Androvax">Androvax (androstenedione albumin)</a></li> <li><a href="/wiki/Cancer_vaccine" title="Cancer vaccine">Cancer vaccines</a> <ul><li><a href="/wiki/ALVAC-CEA_vaccine" title="ALVAC-CEA vaccine">ALVAC-CEA</a></li> <li><a href="/wiki/BCG_vaccine" title="BCG vaccine">BCG</a><sup>#</sup></li> <li><a href="/wiki/Hepatitis_B_vaccine" title="Hepatitis B vaccine">Hepatitis B</a><sup>#</sup></li> <li><a href="/wiki/HPV_vaccine" title="HPV vaccine">HPV</a><sup>#</sup> <ul><li><a href="/wiki/Cervarix" title="Cervarix">Cervarix</a></li> <li><a href="/wiki/Gardasil" title="Gardasil">Gardasil</a></li></ul></li> <li><a href="/wiki/Prostvac" title="Prostvac">Prostvac</a></li></ul></li> <li><a href="/wiki/NicVAX" title="NicVAX">NicVAX</a></li> <li><a href="/wiki/Ovandrotone_albumin" title="Ovandrotone albumin">Ovandrotone albumin (Fecundin)</a></li> <li><a href="/wiki/TA-CD" title="TA-CD">TA-CD</a></li> <li><a href="/wiki/TA-NIC" title="TA-NIC">TA-NIC</a></li> <li>combination: <ul><li><a href="/wiki/DTaP-IPV/Hib_vaccine" title="DTaP-IPV/Hib vaccine">DTaP-IPV/Hib</a></li> <li><a href="/wiki/DTaP-IPV-HepB_vaccine" title="DTaP-IPV-HepB vaccine">DTaP-IPV-HepB</a></li> <li><a href="/wiki/DTwP-HepB-Hib_vaccine" title="DTwP-HepB-Hib vaccine">DTwP-HepB-Hib</a></li> <li><a href="/wiki/Hexavalent_vaccine" title="Hexavalent vaccine">Hexavalent vaccine</a></li></ul></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Inventors/<br />researchers</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Edward_Jenner" title="Edward Jenner">Edward Jenner</a></li> <li><a href="/wiki/Louis_Pasteur" title="Louis Pasteur">Louis Pasteur</a></li> <li><a href="/wiki/Hilary_Koprowski" title="Hilary Koprowski">Hilary Koprowski</a></li> <li><a href="/wiki/Jonas_Salk" title="Jonas Salk">Jonas Salk</a></li> <li><a href="/wiki/John_Franklin_Enders" title="John Franklin Enders">John Franklin Enders</a></li> <li><a href="/wiki/Maurice_Hilleman" title="Maurice Hilleman">Maurice Hilleman</a></li> <li><a href="/wiki/Stanley_Plotkin" title="Stanley Plotkin">Stanley Plotkin</a></li> <li><a href="/wiki/H._Fred_Clark" title="H. Fred Clark">H. Fred Clark</a></li> <li><a href="/wiki/Paul_Offit" title="Paul Offit">Paul Offit</a></li> <li><a href="/wiki/Katalin_Karik%C3%B3" title="Katalin Karikó">Katalin Karikó</a></li> <li><a href="/wiki/Drew_Weissman" title="Drew Weissman">Drew Weissman</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Controversy</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Vaccine_hesitancy" title="Vaccine hesitancy">General</a></li> <li><a href="/wiki/MMR_vaccine_and_autism" title="MMR vaccine and autism">MMR</a> (<a href="/wiki/Lancet_MMR_autism_fraud" title="Lancet MMR autism fraud"><i>Lancet</i> MMR autism fraud</a>)</li> <li><a href="/wiki/National_Childhood_Vaccine_Injury_Act" title="National Childhood Vaccine Injury Act">NCVIA</a></li> <li><a href="/wiki/Pox_party" title="Pox party">Pox party</a></li> <li><a href="/wiki/Thiomersal_and_vaccines" title="Thiomersal and vaccines">Thiomersal</a></li> <li><a href="/wiki/Vaccines_and_SIDS" title="Vaccines and SIDS">Vaccines and SIDS</a></li> <li><i><a href="/wiki/Cedillo_v._Secretary_of_Health_and_Human_Services" title="Cedillo v. Secretary of Health and Human Services">Cedillo v. Secretary of Health and Human Services</a></i></li> <li><a href="/wiki/Alternative_vaccination_schedule" title="Alternative vaccination schedule">Alternative vaccination schedule</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Related</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Epidemiology" title="Epidemiology">Epidemiology</a></li> <li><a href="/wiki/Eradication_of_infectious_diseases" title="Eradication of infectious diseases">Eradication of infectious diseases</a></li> <li><a href="/wiki/Vaccinate_Your_Family" title="Vaccinate Your Family">Vaccinate Your Family</a></li> <li><a href="/wiki/List_of_vaccine_topics" title="List of vaccine topics">List of vaccine topics</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2" style="background: transparent; padding: 0px;"><div><div class="hlist"> <ul><li><sup>#</sup><a href="/wiki/WHO_Model_List_of_Essential_Medicines" title="WHO Model List of Essential Medicines">WHO-EM</a></li> <li><sup>‡</sup><a href="/wiki/List_of_withdrawn_drugs" title="List of withdrawn drugs">Withdrawn</a> from market</li> <li><a class="mw-selflink selflink">Clinical trials</a>: <ul><li><sup>†</sup><a href="/wiki/Phases_of_clinical_research#Phase_III" title="Phases of clinical research">Phase III</a></li> <li><sup>§</sup>Never to phase III</li></ul></li></ul> </div></div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="Statistics" style="padding:3px"><table class="nowraplinks hlist mw-collapsible uncollapsed navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Statistics" title="Template:Statistics"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Statistics" title="Template talk:Statistics"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Statistics" title="Special:EditPage/Template:Statistics"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Statistics" style="font-size:114%;margin:0 4em"><a href="/wiki/Statistics" title="Statistics">Statistics</a></div></th></tr><tr><td class="navbox-abovebelow" colspan="2"><div> <ul><li><a href="/wiki/Outline_of_statistics" title="Outline of statistics">Outline</a></li> <li><a href="/wiki/List_of_statistics_articles" title="List of statistics articles">Index</a></li></ul> </div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible mw-collapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Descriptive_statistics" style="font-size:114%;margin:0 4em"><a href="/wiki/Descriptive_statistics" title="Descriptive statistics">Descriptive statistics</a></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Continuous_probability_distribution" class="mw-redirect" title="Continuous probability distribution">Continuous data</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Central_tendency" title="Central tendency">Center</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Mean" title="Mean">Mean</a> <ul><li><a href="/wiki/Arithmetic_mean" title="Arithmetic mean">Arithmetic</a></li> <li><a href="/wiki/Arithmetic%E2%80%93geometric_mean" title="Arithmetic–geometric mean">Arithmetic-Geometric</a></li> <li><a href="/wiki/Contraharmonic_mean" title="Contraharmonic mean">Contraharmonic</a></li> <li><a href="/wiki/Cubic_mean" title="Cubic mean">Cubic</a></li> <li><a href="/wiki/Generalized_mean" title="Generalized mean">Generalized/power</a></li> <li><a href="/wiki/Geometric_mean" title="Geometric mean">Geometric</a></li> <li><a href="/wiki/Harmonic_mean" title="Harmonic mean">Harmonic</a></li> <li><a href="/wiki/Heronian_mean" title="Heronian mean">Heronian</a></li> <li><a href="/wiki/Heinz_mean" title="Heinz mean">Heinz</a></li> <li><a href="/wiki/Lehmer_mean" title="Lehmer mean">Lehmer</a></li></ul></li> <li><a href="/wiki/Median" title="Median">Median</a></li> <li><a href="/wiki/Mode_(statistics)" title="Mode (statistics)">Mode</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Statistical_dispersion" title="Statistical dispersion">Dispersion</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Average_absolute_deviation" title="Average absolute deviation">Average absolute deviation</a></li> <li><a href="/wiki/Coefficient_of_variation" title="Coefficient of variation">Coefficient of variation</a></li> <li><a href="/wiki/Interquartile_range" title="Interquartile range">Interquartile range</a></li> <li><a href="/wiki/Percentile" title="Percentile">Percentile</a></li> <li><a href="/wiki/Range_(statistics)" title="Range (statistics)">Range</a></li> <li><a href="/wiki/Standard_deviation" title="Standard deviation">Standard deviation</a></li> <li><a href="/wiki/Variance#Sample_variance" title="Variance">Variance</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Shape_of_the_distribution" class="mw-redirect" title="Shape of the distribution">Shape</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Central_limit_theorem" title="Central limit theorem">Central limit theorem</a></li> <li><a href="/wiki/Moment_(mathematics)" title="Moment (mathematics)">Moments</a> <ul><li><a href="/wiki/Kurtosis" title="Kurtosis">Kurtosis</a></li> <li><a href="/wiki/L-moment" title="L-moment">L-moments</a></li> <li><a href="/wiki/Skewness" title="Skewness">Skewness</a></li></ul></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Count_data" title="Count data">Count data</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Index_of_dispersion" title="Index of dispersion">Index of dispersion</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em">Summary tables</th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Contingency_table" title="Contingency table">Contingency table</a></li> <li><a href="/wiki/Frequency_distribution" class="mw-redirect" title="Frequency distribution">Frequency distribution</a></li> <li><a href="/wiki/Grouped_data" title="Grouped data">Grouped data</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Correlation_and_dependence" class="mw-redirect" title="Correlation and dependence">Dependence</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Partial_correlation" title="Partial correlation">Partial correlation</a></li> <li><a href="/wiki/Pearson_correlation_coefficient" title="Pearson correlation coefficient">Pearson product-moment correlation</a></li> <li><a href="/wiki/Rank_correlation" title="Rank correlation">Rank correlation</a> <ul><li><a href="/wiki/Kendall_rank_correlation_coefficient" title="Kendall rank correlation coefficient">Kendall's τ</a></li> <li><a href="/wiki/Spearman%27s_rank_correlation_coefficient" title="Spearman's rank correlation coefficient">Spearman's ρ</a></li></ul></li> <li><a href="/wiki/Scatter_plot" title="Scatter plot">Scatter plot</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Statistical_graphics" title="Statistical graphics">Graphics</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bar_chart" title="Bar chart">Bar chart</a></li> <li><a href="/wiki/Biplot" title="Biplot">Biplot</a></li> <li><a href="/wiki/Box_plot" title="Box plot">Box plot</a></li> <li><a href="/wiki/Control_chart" title="Control chart">Control chart</a></li> <li><a href="/wiki/Correlogram" title="Correlogram">Correlogram</a></li> <li><a href="/wiki/Fan_chart_(statistics)" title="Fan chart (statistics)">Fan chart</a></li> <li><a href="/wiki/Forest_plot" title="Forest plot">Forest plot</a></li> <li><a href="/wiki/Histogram" title="Histogram">Histogram</a></li> <li><a href="/wiki/Pie_chart" title="Pie chart">Pie chart</a></li> <li><a href="/wiki/Q%E2%80%93Q_plot" title="Q–Q plot">Q–Q plot</a></li> <li><a href="/wiki/Radar_chart" title="Radar chart">Radar chart</a></li> <li><a href="/wiki/Run_chart" title="Run chart">Run chart</a></li> <li><a href="/wiki/Scatter_plot" title="Scatter plot">Scatter plot</a></li> <li><a href="/wiki/Stem-and-leaf_display" title="Stem-and-leaf display">Stem-and-leaf display</a></li> <li><a href="/wiki/Violin_plot" title="Violin plot">Violin plot</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible mw-collapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Data_collection" style="font-size:114%;margin:0 4em"><a href="/wiki/Data_collection" title="Data collection">Data collection</a></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Design_of_experiments" title="Design of experiments">Study design</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Effect_size" title="Effect size">Effect size</a></li> <li><a href="/wiki/Missing_data" title="Missing data">Missing data</a></li> <li><a href="/wiki/Optimal_design" class="mw-redirect" title="Optimal design">Optimal design</a></li> <li><a href="/wiki/Statistical_population" title="Statistical population">Population</a></li> <li><a href="/wiki/Replication_(statistics)" title="Replication (statistics)">Replication</a></li> <li><a href="/wiki/Sample_size_determination" title="Sample size determination">Sample size determination</a></li> <li><a href="/wiki/Statistic" title="Statistic">Statistic</a></li> <li><a href="/wiki/Statistical_power" class="mw-redirect" title="Statistical power">Statistical power</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Survey_methodology" title="Survey methodology">Survey methodology</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Sampling_(statistics)" title="Sampling (statistics)">Sampling</a> <ul><li><a href="/wiki/Cluster_sampling" title="Cluster sampling">Cluster</a></li> <li><a href="/wiki/Stratified_sampling" title="Stratified sampling">Stratified</a></li></ul></li> <li><a href="/wiki/Opinion_poll" title="Opinion poll">Opinion poll</a></li> <li><a href="/wiki/Questionnaire" title="Questionnaire">Questionnaire</a></li> <li><a href="/wiki/Standard_error" title="Standard error">Standard error</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Experiment" title="Experiment">Controlled experiments</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Blocking_(statistics)" title="Blocking (statistics)">Blocking</a></li> <li><a href="/wiki/Factorial_experiment" title="Factorial experiment">Factorial experiment</a></li> <li><a href="/wiki/Interaction_(statistics)" title="Interaction (statistics)">Interaction</a></li> <li><a href="/wiki/Random_assignment" title="Random assignment">Random assignment</a></li> <li><a href="/wiki/Randomized_controlled_trial" title="Randomized controlled trial">Randomized controlled trial</a></li> <li><a href="/wiki/Randomized_experiment" title="Randomized experiment">Randomized experiment</a></li> <li><a href="/wiki/Scientific_control" title="Scientific control">Scientific control</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em">Adaptive designs</th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Adaptive_clinical_trial" class="mw-redirect" title="Adaptive clinical trial">Adaptive clinical trial</a></li> <li><a href="/wiki/Stochastic_approximation" title="Stochastic approximation">Stochastic approximation</a></li> <li><a href="/wiki/Up-and-Down_Designs" class="mw-redirect" title="Up-and-Down Designs">Up-and-down designs</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Observational_study" title="Observational study">Observational studies</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Cohort_study" title="Cohort study">Cohort study</a></li> <li><a href="/wiki/Cross-sectional_study" title="Cross-sectional study">Cross-sectional study</a></li> <li><a href="/wiki/Natural_experiment" title="Natural experiment">Natural experiment</a></li> <li><a href="/wiki/Quasi-experiment" title="Quasi-experiment">Quasi-experiment</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible mw-collapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Statistical_inference" style="font-size:114%;margin:0 4em"><a href="/wiki/Statistical_inference" title="Statistical inference">Statistical inference</a></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Statistical_theory" title="Statistical theory">Statistical theory</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Population_(statistics)" class="mw-redirect" title="Population (statistics)">Population</a></li> <li><a href="/wiki/Statistic" title="Statistic">Statistic</a></li> <li><a href="/wiki/Probability_distribution" title="Probability distribution">Probability distribution</a></li> <li><a href="/wiki/Sampling_distribution" title="Sampling distribution">Sampling distribution</a> <ul><li><a href="/wiki/Order_statistic" title="Order statistic">Order statistic</a></li></ul></li> <li><a href="/wiki/Empirical_distribution_function" title="Empirical distribution function">Empirical distribution</a> <ul><li><a href="/wiki/Density_estimation" title="Density estimation">Density estimation</a></li></ul></li> <li><a href="/wiki/Statistical_model" title="Statistical model">Statistical model</a> <ul><li><a href="/wiki/Model_specification" class="mw-redirect" title="Model specification">Model specification</a></li> <li><a href="/wiki/Lp_space" title="Lp space">L<sup><i>p</i></sup> space</a></li></ul></li> <li><a href="/wiki/Statistical_parameter" title="Statistical parameter">Parameter</a> <ul><li><a href="/wiki/Location_parameter" title="Location parameter">location</a></li> <li><a href="/wiki/Scale_parameter" title="Scale parameter">scale</a></li> <li><a href="/wiki/Shape_parameter" title="Shape parameter">shape</a></li></ul></li> <li><a href="/wiki/Parametric_statistics" title="Parametric statistics">Parametric family</a> <ul><li><a href="/wiki/Likelihood_function" title="Likelihood function">Likelihood</a> <a href="/wiki/Monotone_likelihood_ratio" title="Monotone likelihood ratio"><span style="font-size:85%;">(monotone)</span></a></li> <li><a href="/wiki/Location%E2%80%93scale_family" title="Location–scale family">Location–scale family</a></li> <li><a href="/wiki/Exponential_family" title="Exponential family">Exponential family</a></li></ul></li> <li><a href="/wiki/Completeness_(statistics)" title="Completeness (statistics)">Completeness</a></li> <li><a href="/wiki/Sufficient_statistic" title="Sufficient statistic">Sufficiency</a></li> <li><a href="/wiki/Plug-in_principle" class="mw-redirect" title="Plug-in principle">Statistical functional</a> <ul><li><a href="/wiki/Bootstrapping_(statistics)" title="Bootstrapping (statistics)">Bootstrap</a></li> <li><a href="/wiki/U-statistic" title="U-statistic">U</a></li> <li><a href="/wiki/V-statistic" title="V-statistic">V</a></li></ul></li> <li><a href="/wiki/Optimal_decision" title="Optimal decision">Optimal decision</a> <ul><li><a href="/wiki/Loss_function" title="Loss function">loss function</a></li></ul></li> <li><a href="/wiki/Efficiency_(statistics)" title="Efficiency (statistics)">Efficiency</a></li> <li><a href="/wiki/Statistical_distance" title="Statistical distance">Statistical distance</a> <ul><li><a href="/wiki/Divergence_(statistics)" title="Divergence (statistics)">divergence</a></li></ul></li> <li><a href="/wiki/Asymptotic_theory_(statistics)" title="Asymptotic theory (statistics)">Asymptotics</a></li> <li><a href="/wiki/Robust_statistics" title="Robust statistics">Robustness</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Frequentist_inference" title="Frequentist inference">Frequentist inference</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Point_estimation" title="Point estimation">Point estimation</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Estimating_equations" title="Estimating equations">Estimating equations</a> <ul><li><a href="/wiki/Maximum_likelihood" class="mw-redirect" title="Maximum likelihood">Maximum likelihood</a></li> <li><a href="/wiki/Method_of_moments_(statistics)" title="Method of moments (statistics)">Method of moments</a></li> <li><a href="/wiki/M-estimator" title="M-estimator">M-estimator</a></li> <li><a href="/wiki/Minimum_distance_estimation" class="mw-redirect" title="Minimum distance estimation">Minimum distance</a></li></ul></li> <li><a href="/wiki/Bias_of_an_estimator" title="Bias of an estimator">Unbiased estimators</a> <ul><li><a href="/wiki/Minimum-variance_unbiased_estimator" title="Minimum-variance unbiased estimator">Mean-unbiased minimum-variance</a> <ul><li><a href="/wiki/Rao%E2%80%93Blackwell_theorem" title="Rao–Blackwell theorem">Rao–Blackwellization</a></li> <li><a href="/wiki/Lehmann%E2%80%93Scheff%C3%A9_theorem" title="Lehmann–Scheffé theorem">Lehmann–Scheffé theorem</a></li></ul></li> <li><a href="/wiki/Median-unbiased_estimator" class="mw-redirect" title="Median-unbiased estimator">Median unbiased</a></li></ul></li> <li><a href="/wiki/Plug-in_principle" class="mw-redirect" title="Plug-in principle">Plug-in</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Interval_estimation" title="Interval estimation">Interval estimation</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Confidence_interval" title="Confidence interval">Confidence interval</a></li> <li><a href="/wiki/Pivotal_quantity" title="Pivotal quantity">Pivot</a></li> <li><a href="/wiki/Likelihood_interval" class="mw-redirect" title="Likelihood interval">Likelihood interval</a></li> <li><a href="/wiki/Prediction_interval" title="Prediction interval">Prediction interval</a></li> <li><a href="/wiki/Tolerance_interval" title="Tolerance interval">Tolerance interval</a></li> <li><a href="/wiki/Resampling_(statistics)" title="Resampling (statistics)">Resampling</a> <ul><li><a href="/wiki/Bootstrapping_(statistics)" title="Bootstrapping (statistics)">Bootstrap</a></li> <li><a href="/wiki/Jackknife_resampling" title="Jackknife resampling">Jackknife</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Statistical_hypothesis_testing" class="mw-redirect" title="Statistical hypothesis testing">Testing hypotheses</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/One-_and_two-tailed_tests" title="One- and two-tailed tests">1- & 2-tails</a></li> <li><a href="/wiki/Power_(statistics)" title="Power (statistics)">Power</a> <ul><li><a href="/wiki/Uniformly_most_powerful_test" title="Uniformly most powerful test">Uniformly most powerful test</a></li></ul></li> <li><a href="/wiki/Permutation_test" title="Permutation test">Permutation test</a> <ul><li><a href="/wiki/Randomization_test" class="mw-redirect" title="Randomization test">Randomization test</a></li></ul></li> <li><a href="/wiki/Multiple_comparisons" class="mw-redirect" title="Multiple comparisons">Multiple comparisons</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Parametric_statistics" title="Parametric statistics">Parametric tests</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Likelihood-ratio_test" title="Likelihood-ratio test">Likelihood-ratio</a></li> <li><a href="/wiki/Score_test" title="Score test">Score/Lagrange multiplier</a></li> <li><a href="/wiki/Wald_test" title="Wald test">Wald</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/List_of_statistical_tests" title="List of statistical tests">Specific tests</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><td colspan="2" class="navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Z-test" title="Z-test"><i>Z</i>-test <span style="font-size:85%;">(normal)</span></a></li> <li><a href="/wiki/Student%27s_t-test" title="Student's t-test">Student's <i>t</i>-test</a></li> <li><a href="/wiki/F-test" title="F-test"><i>F</i>-test</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Goodness_of_fit" title="Goodness of fit">Goodness of fit</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Chi-squared_test" title="Chi-squared test">Chi-squared</a></li> <li><a href="/wiki/G-test" title="G-test"><i>G</i>-test</a></li> <li><a href="/wiki/Kolmogorov%E2%80%93Smirnov_test" title="Kolmogorov–Smirnov test">Kolmogorov–Smirnov</a></li> <li><a href="/wiki/Anderson%E2%80%93Darling_test" title="Anderson–Darling test">Anderson–Darling</a></li> <li><a href="/wiki/Lilliefors_test" title="Lilliefors test">Lilliefors</a></li> <li><a href="/wiki/Jarque%E2%80%93Bera_test" title="Jarque–Bera test">Jarque–Bera</a></li> <li><a href="/wiki/Shapiro%E2%80%93Wilk_test" title="Shapiro–Wilk test">Normality <span style="font-size:85%;">(Shapiro–Wilk)</span></a></li> <li><a href="/wiki/Likelihood-ratio_test" title="Likelihood-ratio test">Likelihood-ratio test</a></li> <li><a href="/wiki/Model_selection" title="Model selection">Model selection</a> <ul><li><a href="/wiki/Cross-validation_(statistics)" title="Cross-validation (statistics)">Cross validation</a></li> <li><a href="/wiki/Akaike_information_criterion" title="Akaike information criterion">AIC</a></li> <li><a href="/wiki/Bayesian_information_criterion" title="Bayesian information criterion">BIC</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Rank_statistics" class="mw-redirect" title="Rank statistics">Rank statistics</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Sign_test" title="Sign test">Sign</a> <ul><li><a href="/wiki/Sample_median" class="mw-redirect" title="Sample median">Sample median</a></li></ul></li> <li><a href="/wiki/Wilcoxon_signed-rank_test" title="Wilcoxon signed-rank test">Signed rank <span style="font-size:85%;">(Wilcoxon)</span></a> <ul><li><a href="/wiki/Hodges%E2%80%93Lehmann_estimator" title="Hodges–Lehmann estimator">Hodges–Lehmann estimator</a></li></ul></li> <li><a href="/wiki/Mann%E2%80%93Whitney_U_test" title="Mann–Whitney U test">Rank sum <span style="font-size:85%;">(Mann–Whitney)</span></a></li> <li><a href="/wiki/Nonparametric_statistics" title="Nonparametric statistics">Nonparametric</a> <a href="/wiki/Analysis_of_variance" title="Analysis of variance">anova</a> <ul><li><a href="/wiki/Kruskal%E2%80%93Wallis_test" title="Kruskal–Wallis test">1-way <span style="font-size:85%;">(Kruskal–Wallis)</span></a></li> <li><a href="/wiki/Friedman_test" title="Friedman test">2-way <span style="font-size:85%;">(Friedman)</span></a></li> <li><a href="/wiki/Jonckheere%27s_trend_test" title="Jonckheere's trend test">Ordered alternative <span style="font-size:85%;">(Jonckheere–Terpstra)</span></a></li></ul></li> <li><a href="/wiki/Van_der_Waerden_test" title="Van der Waerden test">Van der Waerden test</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Bayesian_inference" title="Bayesian inference">Bayesian inference</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bayesian_probability" title="Bayesian probability">Bayesian probability</a> <ul><li><a href="/wiki/Prior_probability" title="Prior probability">prior</a></li> <li><a href="/wiki/Posterior_probability" title="Posterior probability">posterior</a></li></ul></li> <li><a href="/wiki/Credible_interval" title="Credible interval">Credible interval</a></li> <li><a href="/wiki/Bayes_factor" title="Bayes factor">Bayes factor</a></li> <li><a href="/wiki/Bayes_estimator" title="Bayes estimator">Bayesian estimator</a> <ul><li><a href="/wiki/Maximum_a_posteriori_estimation" title="Maximum a posteriori estimation">Maximum posterior estimator</a></li></ul></li></ul> </div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible mw-collapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="CorrelationRegression_analysis" style="font-size:114%;margin:0 4em"><div class="hlist"><ul><li><a href="/wiki/Correlation_and_dependence" class="mw-redirect" title="Correlation and dependence">Correlation</a></li><li><a href="/wiki/Regression_analysis" title="Regression analysis">Regression analysis</a></li></ul></div></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Correlation_and_dependence" class="mw-redirect" title="Correlation and dependence">Correlation</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Pearson_product-moment_correlation_coefficient" class="mw-redirect" title="Pearson product-moment correlation coefficient">Pearson product-moment</a></li> <li><a href="/wiki/Partial_correlation" title="Partial correlation">Partial correlation</a></li> <li><a href="/wiki/Confounding" title="Confounding">Confounding variable</a></li> <li><a href="/wiki/Coefficient_of_determination" title="Coefficient of determination">Coefficient of determination</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Regression_analysis" title="Regression analysis">Regression analysis</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Errors_and_residuals" title="Errors and residuals">Errors and residuals</a></li> <li><a href="/wiki/Regression_validation" title="Regression validation">Regression validation</a></li> <li><a href="/wiki/Mixed_model" title="Mixed model">Mixed effects models</a></li> <li><a href="/wiki/Simultaneous_equations_model" title="Simultaneous equations model">Simultaneous equations models</a></li> <li><a href="/wiki/Multivariate_adaptive_regression_splines" class="mw-redirect" title="Multivariate adaptive regression splines">Multivariate adaptive regression splines (MARS)</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Linear_regression" title="Linear regression">Linear regression</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Simple_linear_regression" title="Simple linear regression">Simple linear regression</a></li> <li><a href="/wiki/Ordinary_least_squares" title="Ordinary least squares">Ordinary least squares</a></li> <li><a href="/wiki/General_linear_model" title="General linear model">General linear model</a></li> <li><a href="/wiki/Bayesian_linear_regression" title="Bayesian linear regression">Bayesian regression</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em">Non-standard predictors</th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Nonlinear_regression" title="Nonlinear regression">Nonlinear regression</a></li> <li><a href="/wiki/Nonparametric_regression" title="Nonparametric regression">Nonparametric</a></li> <li><a href="/wiki/Semiparametric_regression" title="Semiparametric regression">Semiparametric</a></li> <li><a href="/wiki/Isotonic_regression" title="Isotonic regression">Isotonic</a></li> <li><a href="/wiki/Robust_regression" title="Robust regression">Robust</a></li> <li><a href="/wiki/Heteroscedasticity" class="mw-redirect" title="Heteroscedasticity">Heteroscedasticity</a></li> <li><a href="/wiki/Homoscedasticity" class="mw-redirect" title="Homoscedasticity">Homoscedasticity</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Generalized_linear_model" title="Generalized linear model">Generalized linear model</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Exponential_family" title="Exponential family">Exponential families</a></li> <li><a href="/wiki/Logistic_regression" title="Logistic regression">Logistic <span style="font-size:85%;">(Bernoulli)</span></a> / <a href="/wiki/Binomial_regression" title="Binomial regression">Binomial</a> / <a href="/wiki/Poisson_regression" title="Poisson regression">Poisson regressions</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Partition_of_sums_of_squares" title="Partition of sums of squares">Partition of variance</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Analysis_of_variance" title="Analysis of variance">Analysis of variance (ANOVA, anova)</a></li> <li><a href="/wiki/Analysis_of_covariance" title="Analysis of covariance">Analysis of covariance</a></li> <li><a href="/wiki/Multivariate_analysis_of_variance" title="Multivariate analysis of variance">Multivariate ANOVA</a></li> <li><a href="/wiki/Degrees_of_freedom_(statistics)" title="Degrees of freedom (statistics)">Degrees of freedom</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible mw-collapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Categorical_/_Multivariate_/_Time-series_/_Survival_analysis" style="font-size:114%;margin:0 4em"><a href="/wiki/Categorical_variable" title="Categorical variable">Categorical</a> / <a href="/wiki/Multivariate_statistics" title="Multivariate statistics">Multivariate</a> / <a href="/wiki/Time_series" title="Time series">Time-series</a> / <a href="/wiki/Survival_analysis" title="Survival analysis">Survival analysis</a></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Categorical_variable" title="Categorical variable">Categorical</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Cohen%27s_kappa" title="Cohen's kappa">Cohen's kappa</a></li> <li><a href="/wiki/Contingency_table" title="Contingency table">Contingency table</a></li> <li><a href="/wiki/Graphical_model" title="Graphical model">Graphical model</a></li> <li><a href="/wiki/Poisson_regression" title="Poisson regression">Log-linear model</a></li> <li><a href="/wiki/McNemar%27s_test" title="McNemar's test">McNemar's test</a></li> <li><a href="/wiki/Cochran%E2%80%93Mantel%E2%80%93Haenszel_statistics" title="Cochran–Mantel–Haenszel statistics">Cochran–Mantel–Haenszel statistics</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Multivariate_statistics" title="Multivariate statistics">Multivariate</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/General_linear_model" title="General linear model">Regression</a></li> <li><a href="/wiki/Multivariate_analysis_of_variance" title="Multivariate analysis of variance">Manova</a></li> <li><a href="/wiki/Principal_component_analysis" title="Principal component analysis">Principal components</a></li> <li><a href="/wiki/Canonical_correlation" title="Canonical correlation">Canonical correlation</a></li> <li><a href="/wiki/Linear_discriminant_analysis" title="Linear discriminant analysis">Discriminant analysis</a></li> <li><a href="/wiki/Cluster_analysis" title="Cluster analysis">Cluster analysis</a></li> <li><a href="/wiki/Statistical_classification" title="Statistical classification">Classification</a></li> <li><a href="/wiki/Structural_equation_modeling" title="Structural equation modeling">Structural equation model</a> <ul><li><a href="/wiki/Factor_analysis" title="Factor analysis">Factor analysis</a></li></ul></li> <li><a href="/wiki/Multivariate_distribution" class="mw-redirect" title="Multivariate distribution">Multivariate distributions</a> <ul><li><a href="/wiki/Elliptical_distribution" title="Elliptical distribution">Elliptical distributions</a> <ul><li><a href="/wiki/Multivariate_normal_distribution" title="Multivariate normal distribution">Normal</a></li></ul></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Time_series" title="Time series">Time-series</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;">General</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Decomposition_of_time_series" title="Decomposition of time series">Decomposition</a></li> <li><a href="/wiki/Trend_estimation" class="mw-redirect" title="Trend estimation">Trend</a></li> <li><a href="/wiki/Stationary_process" title="Stationary process">Stationarity</a></li> <li><a href="/wiki/Seasonal_adjustment" title="Seasonal adjustment">Seasonal adjustment</a></li> <li><a href="/wiki/Exponential_smoothing" title="Exponential smoothing">Exponential smoothing</a></li> <li><a href="/wiki/Cointegration" title="Cointegration">Cointegration</a></li> <li><a href="/wiki/Structural_break" title="Structural break">Structural break</a></li> <li><a href="/wiki/Granger_causality" title="Granger causality">Granger causality</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;">Specific tests</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Dickey%E2%80%93Fuller_test" title="Dickey–Fuller test">Dickey–Fuller</a></li> <li><a href="/wiki/Johansen_test" title="Johansen test">Johansen</a></li> <li><a href="/wiki/Ljung%E2%80%93Box_test" title="Ljung–Box test">Q-statistic <span style="font-size:85%;">(Ljung–Box)</span></a></li> <li><a href="/wiki/Durbin%E2%80%93Watson_statistic" title="Durbin–Watson statistic">Durbin–Watson</a></li> <li><a href="/wiki/Breusch%E2%80%93Godfrey_test" title="Breusch–Godfrey test">Breusch–Godfrey</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Time_domain" title="Time domain">Time domain</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Autocorrelation" title="Autocorrelation">Autocorrelation (ACF)</a> <ul><li><a href="/wiki/Partial_autocorrelation_function" title="Partial autocorrelation function">partial (PACF)</a></li></ul></li> <li><a href="/wiki/Cross-correlation" title="Cross-correlation">Cross-correlation (XCF)</a></li> <li><a href="/wiki/Autoregressive%E2%80%93moving-average_model" class="mw-redirect" title="Autoregressive–moving-average model">ARMA model</a></li> <li><a href="/wiki/Box%E2%80%93Jenkins_method" title="Box–Jenkins method">ARIMA model <span style="font-size:85%;">(Box–Jenkins)</span></a></li> <li><a href="/wiki/Autoregressive_conditional_heteroskedasticity" title="Autoregressive conditional heteroskedasticity">Autoregressive conditional heteroskedasticity (ARCH)</a></li> <li><a href="/wiki/Vector_autoregression" title="Vector autoregression">Vector autoregression (VAR)</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Frequency_domain" title="Frequency domain">Frequency domain</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Spectral_density_estimation" title="Spectral density estimation">Spectral density estimation</a></li> <li><a href="/wiki/Fourier_analysis" title="Fourier analysis">Fourier analysis</a></li> <li><a href="/wiki/Least-squares_spectral_analysis" title="Least-squares spectral analysis">Least-squares spectral analysis</a></li> <li><a href="/wiki/Wavelet" title="Wavelet">Wavelet</a></li> <li><a href="/wiki/Whittle_likelihood" title="Whittle likelihood">Whittle likelihood</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Survival_analysis" title="Survival analysis">Survival</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Survival_function" title="Survival function">Survival function</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Kaplan%E2%80%93Meier_estimator" title="Kaplan–Meier estimator">Kaplan–Meier estimator (product limit)</a></li> <li><a href="/wiki/Proportional_hazards_model" title="Proportional hazards model">Proportional hazards models</a></li> <li><a href="/wiki/Accelerated_failure_time_model" title="Accelerated failure time model">Accelerated failure time (AFT) model</a></li> <li><a href="/wiki/First-hitting-time_model" title="First-hitting-time model">First hitting time</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;"><a href="/wiki/Failure_rate" title="Failure rate">Hazard function</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Nelson%E2%80%93Aalen_estimator" title="Nelson–Aalen estimator">Nelson–Aalen estimator</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;font-weight:normal;">Test</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Log-rank_test" class="mw-redirect" title="Log-rank test">Log-rank test</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr></tbody></table><div></div></td></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks mw-collapsible uncollapsed navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Applications" style="font-size:114%;margin:0 4em"><a href="/wiki/List_of_fields_of_application_of_statistics" title="List of fields of application of statistics">Applications</a></div></th></tr><tr><td colspan="2" class="navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Biostatistics" title="Biostatistics">Biostatistics</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bioinformatics" title="Bioinformatics">Bioinformatics</a></li> <li><a class="mw-selflink selflink">Clinical trials</a> / <a href="/wiki/Clinical_study_design" title="Clinical study design">studies</a></li> <li><a href="/wiki/Epidemiology" title="Epidemiology">Epidemiology</a></li> <li><a href="/wiki/Medical_statistics" title="Medical statistics">Medical statistics</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:12.5em"><a href="/wiki/Engineering_statistics" title="Engineering statistics">Engineering statistics</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Chemometrics" title="Chemometrics">Chemometrics</a></li> <li><a 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