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class="vector-toc-numb">2</span> <span>Phases of medical research</span> </div> </a> <button aria-controls="toc-Phases_of_medical_research-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 Phases of medical research subsection</span> </button> <ul id="toc-Phases_of_medical_research-sublist" class="vector-toc-list"> <li id="toc-Basic_medical_research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Basic_medical_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.1</span> <span>Basic medical research</span> </div> </a> <ul id="toc-Basic_medical_research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Pre-clinical_research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Pre-clinical_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.2</span> <span>Pre-clinical research</span> </div> </a> <ul id="toc-Pre-clinical_research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Clinical_research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Clinical_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3</span> <span>Clinical research</span> </div> </a> <ul id="toc-Clinical_research-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Role_of_patients_and_the_public" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Role_of_patients_and_the_public"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>Role of patients and the public</span> </div> </a> <ul id="toc-Role_of_patients_and_the_public-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Funding" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Funding"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Funding</span> </div> </a> <button aria-controls="toc-Funding-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 Funding subsection</span> </button> <ul id="toc-Funding-sublist" class="vector-toc-list"> <li id="toc-Government-funded_biomedical_research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Government-funded_biomedical_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.1</span> <span>Government-funded biomedical research</span> </div> </a> <ul id="toc-Government-funded_biomedical_research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-US_federal_funding_trends" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#US_federal_funding_trends"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.2</span> <span>US federal funding trends</span> </div> </a> <ul id="toc-US_federal_funding_trends-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Privately_(industry)_funded_biomedical_research" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Privately_(industry)_funded_biomedical_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.3</span> <span>Privately (industry) funded biomedical research</span> </div> </a> <ul id="toc-Privately_(industry)_funded_biomedical_research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Conflicts_of_interests" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Conflicts_of_interests"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.4</span> <span>Conflicts of interests</span> </div> </a> <ul id="toc-Conflicts_of_interests-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Transparency_laws" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Transparency_laws"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5</span> <span>Transparency laws</span> </div> </a> <ul id="toc-Transparency_laws-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-History" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#History"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</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-Ancient_to_20th_century_in_other_regions" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Ancient_to_20th_century_in_other_regions"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.1</span> <span>Ancient to 20th century in other regions</span> </div> </a> <ul id="toc-Ancient_to_20th_century_in_other_regions-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-20th_and_21st_century_in_the_United_States" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#20th_and_21st_century_in_the_United_States"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.2</span> <span>20th and 21st century in the United States</span> </div> </a> <ul id="toc-20th_and_21st_century_in_the_United_States-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Regulations_and_guidelines" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Regulations_and_guidelines"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Regulations and guidelines</span> </div> </a> <ul id="toc-Regulations_and_guidelines-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Flaws_and_vulnerabilities" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Flaws_and_vulnerabilities"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>Flaws and vulnerabilities</span> </div> </a> <ul id="toc-Flaws_and_vulnerabilities-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Commercialization" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Commercialization"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>Commercialization</span> </div> </a> <ul id="toc-Commercialization-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Fields_of_research" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Fields_of_research"> <div class="vector-toc-text"> <span class="vector-toc-numb">9</span> <span>Fields of research</span> </div> </a> <ul id="toc-Fields_of_research-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">10</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 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">11</span> <span>References</span> </div> </a> <ul id="toc-References-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 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</div> </div> </nav> <h1 id="firstHeading" class="firstHeading mw-first-heading"><span class="mw-page-title-main">Medical research</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. 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href="https://ca.wikipedia.org/wiki/Investigaci%C3%B3_m%C3%A8dica" title="Investigació mèdica – Catalan" lang="ca" hreflang="ca" data-title="Investigació mèdica" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/Medicinsk_forskning" title="Medicinsk forskning – Danish" lang="da" hreflang="da" data-title="Medicinsk forskning" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Investigaci%C3%B3n_m%C3%A9dica" title="Investigación médica – Spanish" lang="es" hreflang="es" data-title="Investigación médica" 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/%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA_%D9%BE%D8%B2%D8%B4%DA%A9%DB%8C" title="تحقیقات پزشکی – Persian" lang="fa" hreflang="fa" data-title="تحقیقات پزشکی" 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/Recherche_m%C3%A9dicale" title="Recherche médicale – French" lang="fr" hreflang="fr" data-title="Recherche médicale" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%EC%9D%98%ED%95%99_%EC%97%B0%EA%B5%AC" title="의학 연구 – Korean" lang="ko" hreflang="ko" data-title="의학 연구" 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%9A%E0%A4%BF%E0%A4%95%E0%A4%BF%E0%A4%A4%E0%A5%8D%E0%A4%B8%E0%A4%BE_%E0%A4%85%E0%A4%A8%E0%A5%81%E0%A4%B8%E0%A4%82%E0%A4%A7%E0%A4%BE%E0%A4%A8" title="चिकित्सा अनुसंधान – Hindi" lang="hi" hreflang="hi" data-title="चिकित्सा अनुसंधान" data-language-autonym="हिन्दी" data-language-local-name="Hindi" class="interlanguage-link-target"><span>हिन्दी</span></a></li><li class="interlanguage-link interwiki-io mw-list-item"><a href="https://io.wikipedia.org/wiki/Medicinala_serchado" title="Medicinala serchado – Ido" lang="io" hreflang="io" data-title="Medicinala serchado" data-language-autonym="Ido" data-language-local-name="Ido" class="interlanguage-link-target"><span>Ido</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Riset_medis" title="Riset medis – Indonesian" lang="id" hreflang="id" data-title="Riset medis" 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-he mw-list-item"><a href="https://he.wikipedia.org/wiki/%D7%9E%D7%97%D7%A7%D7%A8_%D7%A8%D7%A4%D7%95%D7%90%D7%99" title="מחקר רפואי – Hebrew" lang="he" hreflang="he" data-title="מחקר רפואי" data-language-autonym="עברית" data-language-local-name="Hebrew" class="interlanguage-link-target"><span>עברית</span></a></li><li class="interlanguage-link interwiki-nl mw-list-item"><a href="https://nl.wikipedia.org/wiki/Medisch_onderzoek" title="Medisch onderzoek – Dutch" lang="nl" hreflang="nl" data-title="Medisch onderzoek" data-language-autonym="Nederlands" data-language-local-name="Dutch" class="interlanguage-link-target"><span>Nederlands</span></a></li><li class="interlanguage-link interwiki-new mw-list-item"><a href="https://new.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" title="चिकित्सा – Newari" lang="new" hreflang="new" data-title="चिकित्सा" data-language-autonym="नेपाल भाषा" data-language-local-name="Newari" class="interlanguage-link-target"><span>नेपाल भाषा</span></a></li><li class="interlanguage-link interwiki-ps mw-list-item"><a href="https://ps.wikipedia.org/wiki/%D8%B7%D8%A8%D9%8A_%DA%85%DB%90%DA%93%D9%86%D9%87" title="طبي څېړنه – Pashto" lang="ps" hreflang="ps" data-title="طبي څېړنه" data-language-autonym="پښتو" data-language-local-name="Pashto" class="interlanguage-link-target"><span>پښتو</span></a></li><li class="interlanguage-link interwiki-sr mw-list-item"><a href="https://sr.wikipedia.org/wiki/Medicinsko_istra%C5%BEivanje" title="Medicinsko istraživanje – Serbian" lang="sr" hreflang="sr" data-title="Medicinsko istraživanje" 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/Medicinsko_istra%C5%BEivanje" title="Medicinsko istraživanje – Serbo-Croatian" lang="sh" hreflang="sh" data-title="Medicinsko istraživanje" 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-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/T%C4%B1bb%C3%AE_ara%C5%9Ft%C4%B1rma" title="Tıbbî araştırma – Turkish" lang="tr" hreflang="tr" data-title="Tıbbî araştırma" data-language-autonym="Türkçe" data-language-local-name="Turkish" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-ur mw-list-item"><a href="https://ur.wikipedia.org/wiki/%D8%B7%D8%A8%D9%91%DB%8C_%D8%AA%D8%AD%D9%82%DB%8C%D9%82" title="طبّی تحقیق – Urdu" lang="ur" hreflang="ur" data-title="طبّی تحقیق" data-language-autonym="اردو" data-language-local-name="Urdu" class="interlanguage-link-target"><span>اردو</span></a></li><li class="interlanguage-link interwiki-vi mw-list-item"><a href="https://vi.wikipedia.org/wiki/Nghi%C3%AAn_c%E1%BB%A9u_y_h%E1%BB%8Dc" title="Nghiên cứu y học – Vietnamese" lang="vi" hreflang="vi" data-title="Nghiên cứu y học" 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 badge-Q70893996 mw-list-item" title=""><a href="https://zh.wikipedia.org/wiki/%E5%8C%BB%E5%AD%A6%E7%A0%94%E7%A9%B6" title="医学研究 – Chinese" lang="zh" hreflang="zh" data-title="医学研究" 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 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class="mw-redirectedfrom">(Redirected from <a href="/w/index.php?title=Medical_researcher&redirect=no" class="mw-redirect" title="Medical researcher">Medical researcher</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">Wide array of research</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">For the Biomedical research journals, see <a href="/wiki/Biomedical_Research" title="Biomedical Research">Biomedical Research</a>.</div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">"Biomedical research" redirects here. Not to be confused with <a href="/wiki/Biomedical_science" class="mw-redirect" title="Biomedical science">Biomedical science</a>.</div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Monoclonal_antibodies4.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/e/e7/Monoclonal_antibodies4.jpg/220px-Monoclonal_antibodies4.jpg" decoding="async" width="220" height="147" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/e/e7/Monoclonal_antibodies4.jpg/330px-Monoclonal_antibodies4.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/e/e7/Monoclonal_antibodies4.jpg/440px-Monoclonal_antibodies4.jpg 2x" data-file-width="1350" data-file-height="900" /></a><figcaption><a href="/wiki/Cell_culture" title="Cell culture">Cell culture</a> vials</figcaption></figure> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:UF_Cancer_Genetics_Complex.JPG" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/c/c8/UF_Cancer_Genetics_Complex.JPG/220px-UF_Cancer_Genetics_Complex.JPG" decoding="async" width="220" height="147" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/c/c8/UF_Cancer_Genetics_Complex.JPG/330px-UF_Cancer_Genetics_Complex.JPG 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/c/c8/UF_Cancer_Genetics_Complex.JPG/440px-UF_Cancer_Genetics_Complex.JPG 2x" data-file-width="3888" data-file-height="2592" /></a><figcaption>The <a href="/wiki/University_of_Florida_Cancer_and_Genetics_Research_Complex" title="University of Florida Cancer and Genetics Research Complex">University of Florida Cancer and Genetics Research Complex</a> is an integrated medical research facility.</figcaption></figure> <p><b>Medical research</b> (or <b>biomedical research</b>), also known as <b>health research</b>, refers to the process of using <a href="/wiki/Scientific_method" title="Scientific method">scientific methods</a> with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> </p><p>Medical research encompasses a wide array of research, extending from "<a href="/wiki/Basic_research" title="Basic research">basic research</a>" (also called <i>bench science</i> or <i>bench research</i>),<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> – involving fundamental scientific principles that may apply to a <a href="/wiki/Preclinical_research" class="mw-redirect" title="Preclinical research"><i>preclinical</i></a> understanding – to <a href="/wiki/Clinical_research" title="Clinical research">clinical research</a>, which involves studies of people who may be subjects in <a href="/wiki/Clinical_trial" title="Clinical trial">clinical trials</a>. Within this spectrum is <a href="/wiki/Applied_research" class="mw-redirect" title="Applied research">applied research</a>, or <a href="/wiki/Translational_research" title="Translational research">translational research</a>, conducted to expand knowledge in the field of <a href="/wiki/Medicine" title="Medicine">medicine</a>. </p><p>Both clinical and <a href="/wiki/Phases_of_clinical_research" title="Phases of clinical research">preclinical</a> research phases exist in the <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutical industry</a>'s <a href="/wiki/Drug_development" title="Drug development">drug development</a> pipelines, where the clinical phase is denoted by the term <i>clinical trial</i>. However, only part of the clinical or preclinical research is oriented towards a specific <a href="/wiki/Medication" title="Medication">pharmaceutical</a> purpose. The need for fundamental and mechanism-based understanding, <a href="/wiki/Medical_diagnosis" title="Medical diagnosis">diagnostics</a>, <a href="/wiki/Medical_devices" class="mw-redirect" title="Medical devices">medical devices</a>, and non-pharmaceutical therapies means that <a href="/wiki/Pharmacy" title="Pharmacy">pharmaceutical research</a> is only a small part of medical research. </p><p>Most of the research in the field is pursued by <a href="/wiki/Biomedical_scientist" title="Biomedical scientist">biomedical scientists</a>, but significant contributions are made by other type of <a href="/wiki/Biologist" title="Biologist">biologists</a>. Medical research <a href="/wiki/Human_experimentation" class="mw-redirect" title="Human experimentation">on humans</a> has to strictly follow the <a href="/wiki/Medical_ethics" title="Medical ethics">medical ethics</a> sanctioned in the <a href="/wiki/Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a> and the <a href="/wiki/Institutional_review_board" title="Institutional review board">institutional review board</a> where the research is conducted. In all cases, <a href="/wiki/Research_ethics" title="Research ethics">research ethics</a> are expected. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Impact">Impact</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=1" title="Edit section: Impact"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits of medical research have been <a href="/wiki/Vaccine" title="Vaccine">vaccines</a> for <a href="/wiki/Measles" title="Measles">measles</a> and <a href="/wiki/Polio" title="Polio">polio</a>, <a href="/wiki/Insulin" title="Insulin">insulin</a> treatment for <a href="/wiki/Diabetes" title="Diabetes">diabetes</a>, classes of <a href="/wiki/Antibiotic" title="Antibiotic">antibiotics</a> for treating a host of maladies, medication for high <a href="/wiki/Blood_pressure" title="Blood pressure">blood pressure</a>, improved treatments for <a href="/wiki/AIDS" class="mw-redirect" title="AIDS">AIDS</a>, <a href="/wiki/Statin" title="Statin">statins</a> and other treatments for <a href="/wiki/Atherosclerosis" title="Atherosclerosis">atherosclerosis</a>, new surgical techniques such as <a href="/wiki/Microsurgery" title="Microsurgery">microsurgery</a>, and increasingly successful treatments for <a href="/wiki/Cancer" title="Cancer">cancer</a>. New, beneficial tests and treatments are expected as a result of the <a href="/wiki/Human_Genome_Project" title="Human Genome Project">Human Genome Project</a>. Many challenges remain, however, including the appearance of <a href="/wiki/Antibiotic_resistance" class="mw-redirect" title="Antibiotic resistance">antibiotic resistance</a> and the <a href="/wiki/Obesity_epidemic" class="mw-redirect" title="Obesity epidemic">obesity epidemic</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. (February 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading2"><h2 id="Phases_of_medical_research">Phases of medical research</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=2" title="Edit section: Phases of medical research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Basic_medical_research">Basic medical research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=3" title="Edit section: Basic medical research"><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:Cold_Spring_Harbor_Laboratory.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/8/82/Cold_Spring_Harbor_Laboratory.jpg/220px-Cold_Spring_Harbor_Laboratory.jpg" decoding="async" width="220" height="145" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/82/Cold_Spring_Harbor_Laboratory.jpg/330px-Cold_Spring_Harbor_Laboratory.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/8/82/Cold_Spring_Harbor_Laboratory.jpg 2x" data-file-width="400" data-file-height="263" /></a><figcaption><a href="/wiki/Cold_Spring_Harbor_Laboratory" title="Cold Spring Harbor Laboratory">Cold Spring Harbor Laboratory</a> on <a href="/wiki/Long_Island" title="Long Island">Long Island</a>, home to eight scientists awarded the <a href="/wiki/Nobel_Prize_in_Physiology_or_Medicine" title="Nobel Prize in Physiology or Medicine">Nobel Prize in Physiology or Medicine</a>, is an internationally renowned <a href="/wiki/Basic_research" title="Basic research">basic medical research</a> institution.</figcaption></figure> <p>Example areas in <a href="/wiki/Basic_research" title="Basic research">basic medical research</a> include: <a href="/wiki/Cell_biology" title="Cell biology">cellular</a> and <a href="/wiki/Molecular_biology" title="Molecular biology">molecular biology</a>, <a href="/wiki/Medical_genetics" title="Medical genetics">medical genetics</a>, <a href="/wiki/Immunology" title="Immunology">immunology</a>, <a href="/wiki/Neuroscience" title="Neuroscience">neuroscience</a>, and <a href="/wiki/Psychology" title="Psychology">psychology</a>. Researchers, mainly in universities or government-funded research institutes, aim to establish an understanding of the cellular, molecular and physiological mechanisms of human health and disease.<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. (April 2023)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Pre-clinical_research">Pre-clinical research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=4" title="Edit section: Pre-clinical research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><a href="/wiki/Preclinical_development" title="Preclinical development">Pre-clinical research</a> covers understanding of mechanisms that may lead to clinical research with people. Typically, the work requires no ethical approval, is supervised by scientists rather than <a href="/wiki/Physician" title="Physician">physicians</a>, and is carried out in a university or company, rather than a hospital.<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. (April 2023)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Clinical_research">Clinical research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=5" title="Edit section: Clinical research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><a href="/wiki/Clinical_research" title="Clinical research">Clinical research</a> is carried out with people as the <a href="/wiki/Human_subject_research" title="Human subject research">experimental subjects</a>. It is generally supervised by physicians and conducted by nurses in a medical setting, such as a hospital or research clinic, and requires ethical 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. (February 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading2"><h2 id="Role_of_patients_and_the_public">Role of patients and the public</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=6" title="Edit section: Role of patients and the public"><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">Further information: <a href="/wiki/Patient_and_public_involvement" title="Patient and public involvement">Patient and public involvement</a></div> <p>Besides being participants in a clinical trial, members of the public can actively collaborate with researchers in designing and conducting medical research. 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_3-0" class="reference"><a href="#cite_note-:1-3"><span class="cite-bracket">[</span>3<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 complement 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_4-0" class="reference"><a href="#cite_note-:02-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Funding"><span class="anchor" id="Funding"></span> Funding</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=7" title="Edit section: Funding"><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">Further information: <a href="/wiki/Research_funding" class="mw-redirect" title="Research funding">Research funding</a></div> <figure class="mw-default-size mw-halign-left" typeof="mw:File/Thumb"><a href="/wiki/File:Wellcome.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/8/83/Wellcome.jpg/220px-Wellcome.jpg" decoding="async" width="220" height="165" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/83/Wellcome.jpg/330px-Wellcome.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/8/83/Wellcome.jpg/440px-Wellcome.jpg 2x" data-file-width="2048" data-file-height="1536" /></a><figcaption>The headquarters of the <a href="/wiki/Wellcome_Trust" title="Wellcome Trust">Wellcome Trust</a> in London, United Kingdom</figcaption></figure> <table class="wikitable" align="right"> <caption>Biomedical research and development expenditures classified by region in 2012 in billions of U.S. dollars:<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </caption> <tbody><tr> <th>Region</th> <th>Total</th> <th>Public</th> <th>Industry </th></tr> <tr> <th>United States </th> <td>119.3</td> <td>48.9</td> <td>70.4 </td></tr> <tr> <th>Canada </th> <td>5.3</td> <td>3.3</td> <td>2.0 </td></tr> <tr> <th>Europe </th> <td>81.8</td> <td>28.1</td> <td>53.6 </td></tr> <tr> <th>Asia-Oceania </th> <td>62.0</td> <td>19.3</td> <td>42.7 </td></tr> <tr> <th>Total </th> <td colspan="3" align="center">268.4 </td></tr></tbody></table> <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-Update plainlinks metadata ambox ambox-content ambox-Update" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/5/53/Ambox_current_red_Americas.svg/42px-Ambox_current_red_Americas.svg.png" decoding="async" width="42" height="34" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/5/53/Ambox_current_red_Americas.svg/63px-Ambox_current_red_Americas.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/5/53/Ambox_current_red_Americas.svg/84px-Ambox_current_red_Americas.svg.png 2x" data-file-width="360" data-file-height="290" /></span></span></div></td><td class="mbox-text"><div class="mbox-text-span">This article needs to be <b>updated</b>.<span class="hide-when-compact"> Please help update this article to reflect recent events or newly available information.</span> <span class="date-container"><i>(<span class="date">August 2017</span>)</i></span></div></td></tr></tbody></table> <p><a href="/wiki/Research_funding" class="mw-redirect" title="Research funding">Research funding</a> in many countries derives from research bodies and private organizations which distribute money for equipment, salaries, and research expenses. United States, Europe, Asia, Canada, and Australia combined spent $265.0 billion in 2011, which reflected growth of 3.5% annually from $208.8 billion in 2004.<sup id="cite_ref-:0_6-0" class="reference"><a href="#cite_note-:0-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> The United States contributed 49% of governmental funding from these regions in 2011 compared to 57% in 2004.<sup id="cite_ref-:0_6-1" class="reference"><a href="#cite_note-:0-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> </p><p>In the <a href="/wiki/United_Kingdom" title="United Kingdom">United Kingdom</a>, funding bodies such as the <a href="/wiki/National_Institute_for_Health_and_Care_Research" title="National Institute for Health and Care Research">National Institute for Health and Care Research</a> (NIHR) and the <a href="/wiki/Medical_Research_Council_(UK)" class="mw-redirect" title="Medical Research Council (UK)">Medical Research Council</a> derive their assets from UK tax payers, and distribute revenues to institutions by competitive <a href="/wiki/Grant_(money)" title="Grant (money)">research grants</a>. The <a href="/wiki/Wellcome_Trust" title="Wellcome Trust">Wellcome Trust</a> is the UK's largest non-governmental source of funds for biomedical research and provides over £600 million per year in grants to scientists and funds for research centres.<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> </p><p>In the United States, data from ongoing surveys by the <a href="/wiki/National_Science_Foundation" title="National Science Foundation">National Science Foundation</a> (NSF) show that federal agencies provided only 44% of the $86 billion spent on basic research in 2015.<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> The <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a> and <a href="/wiki/Pharmaceutical_company" class="mw-redirect" title="Pharmaceutical company">pharmaceutical companies</a> collectively contribute $26.4 billion and $27 billion, which constitute 28% and 29% of the total, respectively. Other significant contributors include <a href="/wiki/Biotechnology" title="Biotechnology">biotechnology</a> companies ($17.9 billion, 19% of total), <a href="/wiki/Medical_devices" class="mw-redirect" title="Medical devices">medical device</a> companies ($9.2 billion, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by the <a href="/wiki/Bill_and_Melinda_Gates_Foundation" class="mw-redirect" title="Bill and Melinda Gates Foundation">Bill and Melinda Gates Foundation</a>, contributed about 3% of the funding. These funders are attempting to maximize their <a href="/wiki/Return_on_investment" title="Return on investment">return on investment</a> in <a href="/wiki/Public_health" title="Public health">public health</a>.<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> One method proposed to maximize the return on investment in medicine is to fund the development of <a href="/wiki/Open-source_hardware" title="Open-source hardware">open source hardware</a> for medical research and treatment.<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> </p><p>The enactment of <a href="/wiki/Orphan_drug" title="Orphan drug">orphan drug</a> legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue. </p> <div class="mw-heading mw-heading3"><h3 id="Government-funded_biomedical_research">Government-funded biomedical research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=8" title="Edit section: Government-funded biomedical research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Since the establishment of the National Institutes of Health (NIH) in the mid-1940s, the main source of U.S. federal support of biomedical research, investment priorities and levels of funding have fluctuated. From 1995 to 2010, NIH support of biomedical research increased from 11 billion to 27 billion <sup id="cite_ref-National_Institutes_of_Health_11-0" class="reference"><a href="#cite_note-National_Institutes_of_Health-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> Despite the jump in federal spending, advancements measured by citations to publications and the number of drugs passed by the FDA remained stagnant over the same time span.<sup id="cite_ref-ReferenceA_12-0" class="reference"><a href="#cite_note-ReferenceA-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> Financial projections indicate federal spending will remain constant in the near future.<sup id="cite_ref-ReferenceA_12-1" class="reference"><a href="#cite_note-ReferenceA-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="US_federal_funding_trends">US federal funding trends</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=9" title="Edit section: US federal funding trends"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The National Institutes of Health (NIH) is the agency that is responsible for management of the lion's share of federal funding of biomedical research.<sup id="cite_ref-National_Institutes_of_Health_11-1" class="reference"><a href="#cite_note-National_Institutes_of_Health-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> It funds over 280 areas directly related to health.<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> Over the past century there were two notable periods of NIH support. From 1995 to 1996 funding increased from $8.877 billion to $9.366 billion,<sup id="cite_ref-ReferenceB_14-0" class="reference"><a href="#cite_note-ReferenceB-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> years which represented the start of what is considered the "doubling period" of rapid NIH support.<sup id="cite_ref-National_Institutes_of_Health_11-2" class="reference"><a href="#cite_note-National_Institutes_of_Health-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> The second notable period started in 1997 and ended in 2010, a period where the NIH moved to organize research spending for engagement with the scientific community.<sup id="cite_ref-ReferenceB_14-1" class="reference"><a href="#cite_note-ReferenceB-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Privately_(industry)_funded_biomedical_research"><span id="Privately_.28industry.29_funded_biomedical_research"></span>Privately (industry) funded biomedical research</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=10" title="Edit section: Privately (industry) funded biomedical research"><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">Further information: <a href="/wiki/Industry-funded_research" class="mw-redirect" title="Industry-funded research">industry-funded research</a></div> <p>Since 1980 the share of biomedical research funding from industry sources has grown from 32% to 62%,<sup id="cite_ref-ReferenceC_15-0" class="reference"><a href="#cite_note-ReferenceC-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> which has resulted in the development of numerous life-saving medical advances. The relationship between industry and government-funded research in the US has seen great movement over the years. The 1980 <a href="/wiki/Bayh%E2%80%93Dole_Act" title="Bayh–Dole Act">Bayh–Dole Act</a> was passed by Congress to foster a more constructive relationship between the collaboration of government and industry funded biomedical research. The <a href="/w/index.php?title=Bayh_Doyle_Act&action=edit&redlink=1" class="new" title="Bayh Doyle Act (page does not exist)">Bayh Doyle Act</a> gave private corporations the option of applying for government funded grants for biomedical research which in turn allowed the private corporations to <a href="/wiki/License" title="License">license</a> the technology.<sup id="cite_ref-kellogg.northwestern.edu_16-0" class="reference"><a href="#cite_note-kellogg.northwestern.edu-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> Both government and industry research funding increased rapidly from between the years of 1994–2003; industry saw a compound average annual growth rate of 8.1% a year and slowed only slightly to a compound average annual growth rate of 5.8% from 2003 to 2008.<sup id="cite_ref-17" class="reference"><a href="#cite_note-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Conflicts_of_interests">Conflicts of interests</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=11" title="Edit section: Conflicts of interests"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>"<a href="/wiki/Conflict_of_interest" title="Conflict of interest">Conflict of interest</a>" in the field of medical research has been defined as "a set of conditions in which professional judgment concerning a primary interest (such as a person's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)."<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> </p><p>Regulation on industry funded biomedical research has seen great changes since <a href="/wiki/Samuel_Hopkins_Adams" title="Samuel Hopkins Adams">Samuel Hopkins Adams</a> declaration. In 1906 congress passed the <a href="/wiki/Pure_Food_and_Drugs_Act" class="mw-redirect" title="Pure Food and Drugs Act">Pure Food and Drugs Act</a> of 1906.<sup id="cite_ref-fda.gov_19-0" class="reference"><a href="#cite_note-fda.gov-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> In 1912 Congress passed the Shirley Amendment to prohibit the wide dissemination of false information on pharmaceuticals.<sup id="cite_ref-fda.gov_19-1" class="reference"><a href="#cite_note-fda.gov-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> The Food and Drug Administration was formally created in 1930 under the <a href="/w/index.php?title=McNarey_Mapes_Amendment&action=edit&redlink=1" class="new" title="McNarey Mapes Amendment (page does not exist)">McNarey Mapes Amendment</a> to oversee the regulation of Food and Drugs in the United States.<sup id="cite_ref-fda.gov_19-2" class="reference"><a href="#cite_note-fda.gov-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> In 1962 the <a href="/w/index.php?title=Kefauver-Harris_Amendments_to_the_Food,_Drug_and_Cosmetics_Act&action=edit&redlink=1" class="new" title="Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act (page does not exist)">Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act</a> made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe.<sup id="cite_ref-fda.gov_19-3" class="reference"><a href="#cite_note-fda.gov-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before a drug is brought to the market.<sup id="cite_ref-mttlr.org_20-0" class="reference"><a href="#cite_note-mttlr.org-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> The Kefauver-Harris amendments were met with opposition from industry due to the requirement of lengthier clinical trial periods that would lessen the period of time in which the investor is able to see return on their money. In the pharmaceutical industry patents are typically granted for a 20-year period of time, and most patent applications are submitted during the early stages of the product development.<sup id="cite_ref-mttlr.org_20-1" class="reference"><a href="#cite_note-mttlr.org-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> According to Ariel Katz on average after a patent application is submitted it takes an additional 8 years before the FDA approves a drug for marketing.<sup id="cite_ref-mttlr.org_20-2" class="reference"><a href="#cite_note-mttlr.org-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> As such this would leave a company with only 12 years to market the drug to see a return on their investments. After a sharp decline of new drugs entering the US market following the 1962 Kefauver-Harris amendments economist Sam Petlzman concluded that cost of loss of innovation was greater than the savings recognized by consumers no longer purchasing ineffective drugs.<sup id="cite_ref-mttlr.org_20-3" class="reference"><a href="#cite_note-mttlr.org-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> In 1984 the Hatch-Waxman Act or the Drug Price Competition and Patent Term Restoration Act of 1984 was passed by congress.<sup id="cite_ref-fda.gov_19-4" class="reference"><a href="#cite_note-fda.gov-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> The Hatch-Waxman Act was passed with the idea that giving brand manufacturers the ability to extend their patent by an additional 5 years would create greater incentives for innovation and private sector funding for investment.<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p><p>The relationship that exists with industry funded biomedical research is that of which industry is the financier for academic institutions which in turn employ scientific investigators to conduct research. A fear that exists wherein a project is funded by industry is that firms might negate informing the public of negative effects to better promote their product.<sup id="cite_ref-mttlr.org_20-4" class="reference"><a href="#cite_note-mttlr.org-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> A list of studies shows that public fear of the conflicts of interest that exist when biomedical research is funded by industry can be considered valid after a 2003 publication of "Scope and Impact of Financial Conflicts of Interest in Biomedical Research" in The Journal of American Association of Medicine. This publication included 37 different studies that met specific criteria to determine whether or not an academic institution or scientific investigator funded by industry had engaged in behavior that could be deduced to be a conflict of interest in the field of biomedical research. Survey results from one study concluded that 43% of scientific investigators employed by a participating academic institution had received research related gifts and discretionary funds from industry sponsors.<sup id="cite_ref-ReferenceC_15-1" class="reference"><a href="#cite_note-ReferenceC-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> Another participating institution surveyed showed that 7.6% of investigators were financially tied to research sponsors, including paid speaking engagements (34%), consulting arrangements (33%), advisory board positions (32%) and equity (14%).<sup id="cite_ref-ReferenceC_15-2" class="reference"><a href="#cite_note-ReferenceC-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> A 1994 study concluded that 58% out of 210 life science companies indicated that investigators were required to withhold information pertaining to their research as to extend the life of the interested companies' patents.<sup id="cite_ref-ReferenceC_15-3" class="reference"><a href="#cite_note-ReferenceC-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> Rules and regulations regarding conflict of interest disclosures are being studied by experts in the biomedical research field to eliminate conflicts of interest that could possibly affect the outcomes of biomedical research. </p> <div class="mw-heading mw-heading3"><h3 id="Transparency_laws">Transparency laws</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=12" title="Edit section: Transparency laws"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Two laws which are both still in effect, one passed in 2006 and the other in 2010, were instrumental in defining funding reporting standards for biomedical research, and defining for the first time reporting regulations that were previously not required. The 2006 Federal Funding Accountability and Transparency Act mandates that all entities receiving over $25,000 in federal funds must report annual spending reports, including disclosure of executive salaries.<sup id="cite_ref-hrsa.gov_22-0" class="reference"><a href="#cite_note-hrsa.gov-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> The 2010 amendment to the act mandates that progress reports be submitted along with financial reporting.<sup id="cite_ref-hrsa.gov_22-1" class="reference"><a href="#cite_note-hrsa.gov-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> Data from the federal mandate is managed and made publicly available on usaspending.gov.<sup id="cite_ref-hrsa.gov_22-2" class="reference"><a href="#cite_note-hrsa.gov-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> Aside from the main source, usaspending.gov, other reporting mechanisms exist: Data specifically on biomedical research funding from federal sources is made publicly available by the National Health Expenditure Accounts (NHEA), data on health services research, approximately 0.1% of federal funding on biomedical research, is available through the Coalition of Health Services Research, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the Veterans Health Administration.<sup id="cite_ref-US_Biomedical_Research_2009_23-0" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>Currently, there are not any funding reporting requirements for industry sponsored research, but there has been voluntary movement toward this goal.<sup id="cite_ref-policymed.com_24-0" class="reference"><a href="#cite_note-policymed.com-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> In 2014, major pharmaceutical stakeholders such as Roche and Johnson and Johnson have made financial information publicly available and Pharmaceutical Research and Manufacturers of America (PhRMA), the most prominent professional association for biomedical research companies, has recently begun to provide limited public funding reports.<sup id="cite_ref-policymed.com_24-1" class="reference"><a href="#cite_note-policymed.com-24"><span class="cite-bracket">[</span>24<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=Medical_research&action=edit&section=13" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Ancient_to_20th_century_in_other_regions">Ancient to 20th century in other regions</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=14" title="Edit section: Ancient to 20th century in other regions"><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">Further information: <a href="/wiki/History_of_medicine" title="History of medicine">History of medicine</a> and <a href="/wiki/History_of_pharmacy" title="History of pharmacy">History of pharmacy</a></div> <p>The earliest narrative describing a medical trial is found in the <a href="/wiki/Book_of_Daniel" title="Book of Daniel">Book of Daniel</a>, which says that Babylonian king <a href="/wiki/Nebuchadnezzar" class="mw-redirect" title="Nebuchadnezzar">Nebuchadnezzar</a> ordered youths of royal blood to eat only red meat and wine for three years, while another group of youths ate only beans and water.<sup id="cite_ref-auto_25-0" class="reference"><a href="#cite_note-auto-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> The experiment was intended to determine if a diet of vegetables and water was healthier than a diet of wine and red meat. At the experiment endpoint, the trial accomplished its prerogative: the youths who ate only beans and water were noticeably healthier.<sup id="cite_ref-auto_25-1" class="reference"><a href="#cite_note-auto-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> Scientific curiosity to understand health outcomes from varying treatments has been present for centuries, but it was not until the mid-19th century when an organizational platform was created to support and regulate this curiosity. In 1945, Vannevar Bush said that biomedical scientific research was "the pacemaker of technological progress", an idea which contributed to the initiative to found the National Institutes of Health (NIH) in 1948, a historical benchmark that marked the beginning of a near century substantial investment in biomedical research.<sup id="cite_ref-scienceguide.nl_26-0" class="reference"><a href="#cite_note-scienceguide.nl-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="20th_and_21st_century_in_the_United_States">20th and 21st century in the United States</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=15" title="Edit section: 20th and 21st century in the United States"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The NIH provides more financial support for medical research than any other agency in the world to date and claims responsibility for numerous innovations that have improved global health.<sup id="cite_ref-scienceguide.nl_26-1" class="reference"><a href="#cite_note-scienceguide.nl-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> The historical funding of biomedical research has undergone many changes over the past century. Innovations such as the polio vaccine, antibiotics and antipsychotic agents, developed in the early years of the NIH lead to social and political support of the agency. Political initiatives in the early 1990s lead to a doubling of NIH funding, spurring an era of great scientific progress.<sup id="cite_ref-fas.org_27-0" class="reference"><a href="#cite_note-fas.org-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> There have been dramatic changes in the era since the turn of the 21st century to date; roughly around the start of the century, the cost of trials dramatically increased while the rate of scientific discoveries did not keep pace.<sup id="cite_ref-fas.org_27-1" class="reference"><a href="#cite_note-fas.org-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p><p>Biomedical research spending increased substantially faster than GDP growth over the past decade in the US, between the years of 2003 and 2007 spending increased 14% per year, while GDP growth increased 1% over the same period (both measures adjusted for inflation).<sup id="cite_ref-US_Biomedical_Research_2009_23-1" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Industry, not-for-profit entities, state and federal funding spending combined accounted for an increase in funding from $75.5 billion in 2003 to $101.1 billion in 2007.<sup id="cite_ref-US_Biomedical_Research_2009_23-2" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Due to the immediacy of federal financing priorities and stagnant corporate spending during the recession, biomedical research spending decreased 2% in real terms in 2008.<sup id="cite_ref-US_Biomedical_Research_2009_23-3" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Despite an overall increase of investment in biomedical research, there has been stagnation, and in some areas a marked decline in the number of drug and device approvals over the same time period.<sup id="cite_ref-US_Biomedical_Research_2009_23-4" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>As of 2010, industry sponsored research accounts for 58% of expenditures, NIH for 27% of expenditures, state governments for 5% of expenditures, non NIH-federal sources for 5% of expenditures and not-for-profit entities accounted for 4% of support.<sup id="cite_ref-US_Biomedical_Research_2009_23-5" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Federally funded biomedical research expenditures increased nominally, 0.7% (adjusted for inflation), from 2003 to 2007.<sup id="cite_ref-US_Biomedical_Research_2009_23-6" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Previous reports showed a stark contrast in federal investment, from 1994 to 2003, federal funding increased 100% (adjusted for inflation).<sup id="cite_ref-US_Biomedical_Research_2009_23-7" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>The NIH manages the majority, over 85%, of federal biomedical research expenditures.<sup id="cite_ref-US_Biomedical_Research_2009_23-8" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> NIH support for biomedical research decreased from $31.8 billion in 2003, to $29.0 billion in 2007, a 25% decline (in real terms adjusted for inflation), while non-NIH federal funding allowed for the maintenance of government financial support levels through the era (the 0.7% four-year increase). Spending from industry-initiated research increased 25% (adjusted for inflation) over the same time period of time, from 2003 to 2007, an increase from $40 billion in 2003, to $58.6 billion in 2007.<sup id="cite_ref-US_Biomedical_Research_2009_23-9" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Industry sourced expenditures from 1994 to 2003 showed industry sponsored research funding increased 8.1%, a stark contrast to 25% increase in recent years.<sup id="cite_ref-US_Biomedical_Research_2009_23-10" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>Of industry sponsored research, pharmaceutical firm spending was the greatest contributor from all industry sponsored biomedical research spending, but only increased 15% (adjusted for inflation) from 2003 to 2007, while device and biotechnology firms accounted for the majority of the spending.<sup id="cite_ref-US_Biomedical_Research_2009_23-11" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> The stock performance, a measure that can be an indication of future firm growth or technological direction, has substantially increased for both predominantly medical device and biotechnology producers.<sup id="cite_ref-US_Biomedical_Research_2009_23-12" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Contributing factors to this growth are thought to be less rigorous FDA approval requirements for devices as opposed to drugs, lower cost of trials, lower pricing and profitability of products and predictable influence of new technology due to a limited number of competitors.<sup id="cite_ref-US_Biomedical_Research_2009_23-13" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Another visible shift during the era was a shift in focus to late stage research trials; formerly dispersed, since 1994 an increasingly large portion of industry-sponsored research was late phase trials rather than early-experimental phases now accounting for the majority of industry sponsored research.<sup id="cite_ref-US_Biomedical_Research_2009_23-14" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> This shift is attributable to a lower risk investment and a shorter development to market schedule.<sup id="cite_ref-US_Biomedical_Research_2009_23-15" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> The low risk preference is also reflected in the trend of large pharmaceutical firms acquiring smaller companies that hold patents to newly developed drug or device discoveries which have not yet passed federal regulation (large companies are mitigating their risk by purchasing technology created by smaller companies in early-phase high-risk studies).<sup id="cite_ref-US_Biomedical_Research_2009_23-16" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Medical research support from universities increased from $22 billion in 2003 to $27.7 billion in 2007, a 7.8% increase (adjusted for inflation).<sup id="cite_ref-US_Biomedical_Research_2009_23-17" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> In 2007 the most heavily funded institutions received 20% of HIN medical research funding, and the top 50 institutions received 58% of NIH medical research funding, the percent of funding allocated to the largest institutions is a trend which has increased only slightly over data from 1994.<sup id="cite_ref-US_Biomedical_Research_2009_23-18" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> Relative to federal and private funding, health policy and service research accounted for a nominal amount of sponsored research; health policy and service research was funded $1.8 billion in 2003, which increased to $2.2 billion in 2008.<sup id="cite_ref-US_Biomedical_Research_2009_23-19" class="reference"><a href="#cite_note-US_Biomedical_Research_2009-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>Stagnant rates of investment from the US government over the past decade may be in part attributable to challenges that plague the field. To date, only two-thirds of published drug trial findings have results that can be re-produced,<sup id="cite_ref-drugabuse.gov_28-0" class="reference"><a href="#cite_note-drugabuse.gov-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> which raises concerns from a US regulatory standpoint where great investment has been made in research ethics and standards, yet trial results remain inconsistent. Federal agencies have called upon greater regulation to address these problems; a spokesman from the National Institute of Neurological Disorders and Stroke, an agency of the NIH, stated that there is "widespread poor reporting of experimental design in articles and grant applications, that animal research should follow a core set of research parameters, and that a concerted effort by all stakeholders is needed to disseminate best reporting practices and put them into practice".<sup id="cite_ref-drugabuse.gov_28-1" class="reference"><a href="#cite_note-drugabuse.gov-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Regulations_and_guidelines">Regulations and guidelines</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=16" title="Edit section: Regulations and guidelines"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medical research is highly regulated. National regulatory authorities are appointed in most countries to oversee and monitor medical research, such as for the development and distribution of new drugs. In the United States, 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> oversees new drug development; in Europe, the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (see also <a href="/wiki/EudraLex" title="EudraLex">EudraLex</a>); and in <a href="/wiki/Japan" title="Japan">Japan</a>, the <a href="/wiki/Ministry_of_Health,_Labour_and_Welfare" title="Ministry of Health, Labour and Welfare">Ministry of Health, Labour and Welfare</a>. The <a href="/wiki/World_Medical_Association" title="World Medical Association">World Medical Association</a> develops the ethical standards for medical professionals involved in medical research. The most fundamental of them is the <a href="/wiki/Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a>. 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) works on the creation of rules and guidelines for the development of new medication, such as the guidelines for <a href="/wiki/Good_clinical_practice" title="Good clinical practice">Good Clinical Practice</a> (GCP). All ideas of regulation are based on a country's ethical standards code. This is why treatment of a particular disease in one country may not be allowed, but is in another. </p> <div class="mw-heading mw-heading2"><h2 id="Flaws_and_vulnerabilities">Flaws and vulnerabilities</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=17" title="Edit section: Flaws and vulnerabilities"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>A major flaw and vulnerability in biomedical research appears to be the hypercompetition for the resources and positions that are required to conduct science. The competition seems to suppress the creativity, cooperation, risk-taking, and original thinking required to make fundamental discoveries. Other consequences of today's highly pressured environment for research appear to be a substantial number of research publications whose results cannot be replicated, and perverse incentives in research funding that encourage grantee institutions to grow without making sufficient investments in their own faculty and facilities.<sup id="cite_ref-pmid24733905_29-0" class="reference"><a href="#cite_note-pmid24733905-29"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-30" class="reference"><a href="#cite_note-30"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-31" class="reference"><a href="#cite_note-31"><span class="cite-bracket">[</span>31<span class="cite-bracket">]</span></a></sup><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><sup id="cite_ref-pmid27786221_33-0" class="reference"><a href="#cite_note-pmid27786221-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> Other risky trends include a decline in the share of key research grants going to younger scientists, as well as a steady rise in the age at which investigators receive their first funding.<sup id="cite_ref-pmid25561560_34-0" class="reference"><a href="#cite_note-pmid25561560-34"><span class="cite-bracket">[</span>34<span class="cite-bracket">]</span></a></sup> </p><p>A significant flaw in biomedical research is the toxic culture that particularly impacts medical students and early career researchers. They face challenges such as bullying, harassment, and unethical authorship practices. Intense competition for funding and publication pressures fosters a climate of secrecy and self-protection, stifling creativity and collaboration. The power imbalance in academic hierarchies exacerbates these issues, with junior researchers often subjected to exploitative practices and denied proper recognition for their contributions.<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> <div class="mw-heading mw-heading2"><h2 id="Commercialization">Commercialization</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=18" title="Edit section: Commercialization"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>After clinical research, medical therapies are typically commercialized by private companies such as <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutical companies</a> or <a href="/wiki/Medical_device" title="Medical device">medical device</a> company. In the United States, one estimate found that in 2011, one-third of Medicare physician and outpatient hospital spending was on new technologies unavailable in the prior decade.<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><p>Medical therapies are constantly being researched, so the difference between a therapy which is investigational versus <a href="/wiki/Standard_of_care" title="Standard of care">standard of care</a> is not always clear, particularly given cost-effectiveness considerations.<sup id="cite_ref-37" class="reference"><a href="#cite_note-37"><span class="cite-bracket">[</span>37<span class="cite-bracket">]</span></a></sup> Payers have <a href="/wiki/Utilization_management" title="Utilization management">utilization management</a> clinical guidelines which do not pay for "experimental or investigational" therapies, or may require that the therapy is <a href="/wiki/Medical_necessity" title="Medical necessity">medically necessary</a> or superior to cheaper treatments. For example, <a href="/wiki/Proton_therapy" title="Proton therapy">proton therapy</a> was approved by the FDA, but private health insurers in the United States considered it unproven or unnecessary given its high cost, although it was ultimately covered for certain cancers.<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> </p> <div class="mw-heading mw-heading2"><h2 id="Fields_of_research">Fields of research</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Medical_research&action=edit&section=19" title="Edit section: Fields of research"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Fields of biomedical research include: </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" style="column-width: 30em;"> <ul><li><a href="/wiki/Aging" class="mw-redirect" title="Aging">Aging</a></li> <li><a href="/wiki/Anatomy" title="Anatomy">Anatomy</a></li> <li><a href="/wiki/Behavioral_health" class="mw-redirect" title="Behavioral health">Behavioral health</a></li> <li><a href="/wiki/Biochemistry" title="Biochemistry">Biochemistry</a></li> <li><a href="/wiki/Biomaterials" class="mw-redirect" title="Biomaterials">Biomaterials</a></li> <li><a href="/wiki/Biology" title="Biology">Biology</a> <ul><li><a href="/wiki/Cellular_biology" class="mw-redirect" title="Cellular biology">Cellular biology</a></li> <li><a href="/wiki/Molecular_biology" title="Molecular biology">Molecular biology</a></li></ul></li> <li><a href="/wiki/Cardiovascular" class="mw-redirect" title="Cardiovascular">Cardiovascular</a></li> <li><a href="/wiki/Biostatistics" title="Biostatistics">Biostatistics</a></li> <li><a href="/wiki/Cancer" title="Cancer">Cancer</a></li> <li><a href="/wiki/Chemistry" title="Chemistry">Chemistry</a></li> <li><a href="/wiki/Diabetes" title="Diabetes">Diabetes</a></li> <li><a href="/wiki/Endocrinology" title="Endocrinology">Endocrinology</a></li> <li><a href="/wiki/Epigenetics" title="Epigenetics">Epigenetics</a></li> <li><a href="/wiki/Epidemiology" title="Epidemiology">Epidemiology</a></li> <li><a href="/wiki/Genetics" title="Genetics">Genetics</a></li> <li><a href="/wiki/Immunology" title="Immunology">Immunology</a></li> <li><a href="/wiki/Microbiology" title="Microbiology">Microbiology</a></li> <li><a href="/wiki/Nanomaterials" title="Nanomaterials">Nanomaterials</a></li> <li><a href="/wiki/Neuroendocrinology" title="Neuroendocrinology">Neuroendocrinology</a></li> <li><a href="/wiki/Neuroscience" title="Neuroscience">Neuroscience</a></li> <li><a href="/wiki/Ophthalmology" title="Ophthalmology">Ophthalmology</a></li> <li><a href="/wiki/Pharmacology" title="Pharmacology">Pharmacology</a></li> <li><a href="/wiki/Physiology" title="Physiology">Physiology</a></li> <li><a href="/wiki/Preventive_medicine" class="mw-redirect" title="Preventive medicine">Preventive medicine</a>           </li> <li><a href="/wiki/Psychopharmacology#Psychopharmacological_research" title="Psychopharmacology">Psychopharmacology</a></li> <li><a href="/wiki/Public_health" title="Public health">Public health</a></li> <li><a href="/wiki/Tissue_engineering" title="Tissue engineering">Tissue engineering</a></li> <li><a href="/wiki/Virology" title="Virology">Virology</a></li> <li><a href="/wiki/Otolaryngology" class="mw-redirect" title="Otolaryngology">Otolaryngology</a></li> <li><a href="/wiki/Toxicology" title="Toxicology">Toxicology</a></li> <li><a href="/wiki/Angiology" title="Angiology">Angiology</a></li> <li><a href="/wiki/Palliative_medicine" class="mw-redirect" title="Palliative medicine">Palliative medicine</a></li></ul></div> <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=Medical_research&action=edit&section=20" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1184024115"><div class="div-col" style="column-width: 30em;"> <ul><li><a href="/wiki/Animal_testing" title="Animal testing">Animal testing</a></li> <li><a href="/wiki/Biomedical_informatics" class="mw-redirect" title="Biomedical informatics">Biomedical informatics</a></li> <li><a href="/wiki/Biomedical_research_in_the_United_States" title="Biomedical research in the United States">Biomedical research in the United States</a></li> <li><a href="/wiki/Biomedical_technology" title="Biomedical technology">Biomedical technology</a></li> <li><a href="/wiki/Biomedicine" title="Biomedicine">Biomedicine</a></li> <li><a href="/wiki/Cancer_research" title="Cancer research">Cancer research</a></li> <li><a href="/wiki/Gain-of-function_research" title="Gain-of-function research">Gain-of-function research</a></li> <li><a href="/wiki/Medical_research_scientist" class="mw-redirect" title="Medical research scientist">Medical research scientist</a></li> <li><a href="/wiki/Medical_Scientist_Training_Program" title="Medical Scientist Training Program">Medical Scientist Training Program</a></li> <li><a href="/wiki/Pharmaceutical_company" class="mw-redirect" title="Pharmaceutical company">Pharmaceutical company</a></li> <li><a href="/wiki/Preclinical_imaging" title="Preclinical imaging">Preclinical imaging</a></li> <li><a href="/wiki/Title_21_of_the_Code_of_Federal_Regulations" title="Title 21 of the Code of Federal Regulations">Title 21 of the Code of Federal Regulations</a> (US)           </li></ul></div> <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=Medical_research&action=edit&section=21" 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 .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist reflist-columns references-column-width" style="column-width: 30em;"> <ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <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 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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"><style data-mw-deduplicate="TemplateStyles:r1038841319">.mw-parser-output .tooltip-dotted{border-bottom:1px dotted;cursor:help}</style><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1038841319"></div><div role="navigation" class="navbox authority-control" aria-labelledby="Authority_control_databases_frameless&#124;text-top&#124;10px&#124;alt=Edit_this_at_Wikidata&#124;link=https&#58;//www.wikidata.org/wiki/Q2752427#identifiers&#124;class=noprint&#124;Edit_this_at_Wikidata" style="padding:3px"><table class="nowraplinks hlist mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><div id="Authority_control_databases_frameless&#124;text-top&#124;10px&#124;alt=Edit_this_at_Wikidata&#124;link=https&#58;//www.wikidata.org/wiki/Q2752427#identifiers&#124;class=noprint&#124;Edit_this_at_Wikidata" style="font-size:114%;margin:0 4em"><a href="/wiki/Help:Authority_control" title="Help:Authority control">Authority control databases</a> <span class="mw-valign-text-top noprint" typeof="mw:File/Frameless"><a href="https://www.wikidata.org/wiki/Q2752427#identifiers" title="Edit this at Wikidata"><img alt="Edit this at Wikidata" src="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/10px-OOjs_UI_icon_edit-ltr-progressive.svg.png" decoding="async" width="10" height="10" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/15px-OOjs_UI_icon_edit-ltr-progressive.svg.png 1.5x, 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