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href="https://bn.wikipedia.org/wiki/%E0%A6%B0%E0%A7%8B%E0%A6%97%E0%A7%80%E0%A6%AD%E0%A6%BF%E0%A6%A4%E0%A7%8D%E0%A6%A4%E0%A6%BF%E0%A6%95_%E0%A6%97%E0%A6%AC%E0%A7%87%E0%A6%B7%E0%A6%A3%E0%A6%BE" title="রোগীভিত্তিক গবেষণা – Bangla" lang="bn" hreflang="bn" data-title="রোগীভিত্তিক গবেষণা" data-language-autonym="বাংলা" data-language-local-name="Bangla" class="interlanguage-link-target"><span>বাংলা</span></a></li><li class="interlanguage-link interwiki-be mw-list-item"><a href="https://be.wikipedia.org/wiki/%D0%9A%D0%BB%D1%96%D0%BD%D1%96%D1%87%D0%BD%D0%B0%D0%B5_%D0%B4%D0%B0%D1%81%D0%BB%D0%B5%D0%B4%D0%B0%D0%B2%D0%B0%D0%BD%D0%BD%D0%B5" title="Клінічнае даследаванне – Belarusian" lang="be" hreflang="be" data-title="Клінічнае даследаванне" data-language-autonym="Беларуская" data-language-local-name="Belarusian" class="interlanguage-link-target"><span>Беларуская</span></a></li><li class="interlanguage-link interwiki-bg mw-list-item"><a href="https://bg.wikipedia.org/wiki/%D0%9A%D0%BB%D0%B8%D0%BD%D0%B8%D1%87%D0%BD%D0%BE_%D0%B8%D0%B7%D1%81%D0%BB%D0%B5%D0%B4%D0%B2%D0%B0%D0%BD%D0%B5" title="Клинично изследване – Bulgarian" lang="bg" hreflang="bg" data-title="Клинично изследване" data-language-autonym="Български" data-language-local-name="Bulgarian" class="interlanguage-link-target"><span>Български</span></a></li><li class="interlanguage-link interwiki-ca mw-list-item"><a href="https://ca.wikipedia.org/wiki/Recerca_cl%C3%ADnica" title="Recerca clínica – Catalan" lang="ca" hreflang="ca" data-title="Recerca clínica" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Investigaciones_cl%C3%ADnicas" title="Investigaciones clínicas – Spanish" lang="es" hreflang="es" data-title="Investigaciones clínicas" 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_%D8%A8%D8%A7%D9%84%DB%8C%D9%86%DB%8C" title="تحقیقات بالینی – Persian" lang="fa" hreflang="fa" data-title="تحقیقات بالینی" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Penelitian_klinis" title="Penelitian klinis – Indonesian" lang="id" hreflang="id" data-title="Penelitian klinis" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-mr mw-list-item"><a href="https://mr.wikipedia.org/wiki/%E0%A4%95%E0%A5%8D%E0%A4%B2%E0%A4%BF%E0%A4%A8%E0%A4%BF%E0%A4%95%E0%A4%B2_%E0%A4%B0%E0%A4%BF%E0%A4%B8%E0%A4%B0%E0%A5%8D%E0%A4%9A" title="क्लिनिकल रिसर्च – Marathi" lang="mr" hreflang="mr" data-title="क्लिनिकल रिसर्च" data-language-autonym="मराठी" data-language-local-name="Marathi" class="interlanguage-link-target"><span>मराठी</span></a></li><li class="interlanguage-link interwiki-ms mw-list-item"><a href="https://ms.wikipedia.org/wiki/Penyelidikan_klinikal" title="Penyelidikan klinikal – Malay" lang="ms" hreflang="ms" data-title="Penyelidikan klinikal" data-language-autonym="Bahasa Melayu" data-language-local-name="Malay" class="interlanguage-link-target"><span>Bahasa Melayu</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E8%87%A8%E5%BA%8A%E7%A0%94%E7%A9%B6" title="臨床研究 – Japanese" lang="ja" hreflang="ja" data-title="臨床研究" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-pt mw-list-item"><a href="https://pt.wikipedia.org/wiki/Investiga%C3%A7%C3%A3o_cl%C3%ADnica" title="Investigação clínica – Portuguese" lang="pt" hreflang="pt" data-title="Investigação clínica" data-language-autonym="Português" data-language-local-name="Portuguese" class="interlanguage-link-target"><span>Português</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/Kliininen_tutkimus" title="Kliininen tutkimus – Finnish" lang="fi" hreflang="fi" data-title="Kliininen tutkimus" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-uk badge-Q70893996 mw-list-item" title=""><a href="https://uk.wikipedia.org/wiki/%D0%9A%D0%BB%D1%96%D0%BD%D1%96%D1%87%D0%BD%D1%96_%D0%B4%D0%BE%D1%81%D0%BB%D1%96%D0%B4%D0%B6%D0%B5%D0%BD%D0%BD%D1%8F" title="Клінічні дослідження – Ukrainian" lang="uk" hreflang="uk" data-title="Клінічні дослідження" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-vi mw-list-item"><a href="https://vi.wikipedia.org/wiki/Nghi%C3%AAn_c%E1%BB%A9u_l%C3%A2m_s%C3%A0ng" title="Nghiên cứu lâm sàng – Vietnamese" lang="vi" hreflang="vi" data-title="Nghiên cứu lâm sàng" data-language-autonym="Tiếng Việt" data-language-local-name="Vietnamese" class="interlanguage-link-target"><span>Tiếng Việt</span></a></li><li class="interlanguage-link interwiki-zh-yue mw-list-item"><a href="https://zh-yue.wikipedia.org/wiki/%E8%87%A8%E5%BA%8A%E7%A0%94%E7%A9%B6" title="臨床研究 – Cantonese" lang="yue" hreflang="yue" data-title="臨床研究" 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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">See also: <a href="/wiki/Clinical_trial" title="Clinical trial">Clinical trial</a></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">"Clinical science" redirects here. For the journal, see <a href="/wiki/Clinical_Science_(journal)" title="Clinical Science (journal)">Clinical Science (journal)</a>.</div> <p><b>Clinical research</b> is a branch of <a href="/wiki/Medical_research" title="Medical research">medical research</a> that involves people and aims to determine the effectiveness (<a href="/wiki/Efficacy" title="Efficacy">efficacy</a>) and safety of <a href="/wiki/Medications" class="mw-redirect" title="Medications">medications</a>, <a href="/wiki/Medical_device" title="Medical device">devices</a>, <a href="/wiki/Diagnostics" class="mw-redirect" title="Diagnostics">diagnostic products</a>, and <a href="/wiki/Medical_treatment" class="mw-redirect" title="Medical treatment">treatment regimens</a> intended for improving human health.<sup id="cite_ref-nlm_1-0" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-nia_2-0" class="reference"><a href="#cite_note-nia-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms. </p><p>Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.<sup id="cite_ref-nlm_1-1" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-nia_2-1" class="reference"><a href="#cite_note-nia-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Description">Description</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=1" title="Edit section: Description"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (<a href="/wiki/Clinical_trial" title="Clinical trial">clinical trials</a>) or <a href="/wiki/Observational_study" title="Observational study">observational studies</a> on human participants.<sup id="cite_ref-nlm_1-2" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-0" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> Clinical research can cover any medical method or product from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety <a href="/wiki/Toxicity" title="Toxicity">toxicity</a> if applicable and <a href="/wiki/Efficacy" title="Efficacy">efficacy</a>, if possible at this early stage) are studied.<sup id="cite_ref-nlm_1-3" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-1" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> </p><p>The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. Clinical research is often conducted at academic medical centers and affiliated research study sites.<sup id="cite_ref-nia_2-2" class="reference"><a href="#cite_note-nia-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal <a href="/wiki/Institutional_review_board" title="Institutional review board">Institutional Review Boards</a> that oversee the ethical conduct of medical research.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Patient_and_public_involvement">Patient and public involvement</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=2" title="Edit section: Patient and public involvement"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Besides being participants in a clinical trial, members of the public can actively collaborate with researchers in designing and conducting clinical research.<sup id="cite_ref-nlm_1-4" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-nia_2-3" class="reference"><a href="#cite_note-nia-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> 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_5-0" class="reference"><a href="#cite_note-:1-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> PPI can improve the quality of research and make it more relevant and accessible. People with current or past experience of illness can provide a different perspective than professionals and compliment their knowledge. Through their personal knowledge they can identify research topics that are relevant and important to those living with an illness or using a service. They can also help to make the research more grounded in the needs of the specific communities they are part of. Public contributors can also ensure that the research is presented in <a href="/wiki/Plain_language" title="Plain language">plain language</a> that is clear to the wider society and the specific groups it is most relevant for.<sup id="cite_ref-:02_6-0" class="reference"><a href="#cite_note-:02-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-:0_7-0" class="reference"><a href="#cite_note-:0-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Phases">Phases</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=3" title="Edit section: Phases"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Phases_of_clinical_research" title="Phases of clinical research">Phases of clinical research</a></div> <p>Following <a href="/wiki/Preclinical_development" title="Preclinical development">preclinical research</a>, clinical trials involving new drugs are commonly classified into four phases.<sup id="cite_ref-nlm_1-5" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-2" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-ddp_8-0" class="reference"><a href="#cite_note-fda-ddp-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Each phase of the drug approval process is treated as a separate <a href="/wiki/Clinical_trial" title="Clinical trial">clinical trial</a>.<sup id="cite_ref-nlm_1-6" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-3" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in the general population. Phase IV is <i>post-approval</i> studies.<sup id="cite_ref-fda-ddp_8-1" class="reference"><a href="#cite_note-fda-ddp-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> </p><p>Phase I includes 20 to 100 healthy volunteers or individuals with the disease or condition.<sup id="cite_ref-nlm_1-7" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-4" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> This study typically lasts several months and its purpose is to prove safety and an effective dosage. Phase II includes a larger number of individual participants in the range of 100–300, and Phase III includes some 1000-3000 participants to assess efficacy and safety of the drug at different doses.<sup id="cite_ref-nlm_1-8" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-types_3-5" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-fda-ddp_8-2" class="reference"><a href="#cite_note-fda-ddp-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Only 25-30% of drugs advance to the end of Phase III.<sup id="cite_ref-fda-ddp_8-3" class="reference"><a href="#cite_note-fda-ddp-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Clinical_research_by_country">Clinical research by country</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=4" title="Edit section: Clinical research by country"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="United_States">United States</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=5" title="Edit section: United States"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the <a href="/wiki/United_States" title="United States">United States</a>, when a test article is unapproved or not yet cleared by the <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (<a href="/wiki/FDA" class="mw-redirect" title="FDA">FDA</a>), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the preclinical studies or other supporting evidence, or case studies of off label use are submitted to the FDA in support of an <a href="/wiki/Investigational_New_Drug" title="Investigational New Drug">Investigational New Drug</a> application.<sup id="cite_ref-fda-types_3-6" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> </p><p>Where devices are concerned the submission to the FDA would be for an <a href="/wiki/Investigational_Device_Exemption" class="mw-redirect" title="Investigational Device Exemption">Investigational Device Exemption</a> application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA.<sup id="cite_ref-fda-types_3-7" class="reference"><a href="#cite_note-fda-types-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> In addition, clinical research may require <a href="/wiki/Institutional_Review_Board" class="mw-redirect" title="Institutional Review Board">Institutional Review Board</a> or Research Ethics Board and possibly other institutional committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee or Radioactive Drug Research Committee.<sup id="cite_ref-nlm_1-9" class="reference"><a href="#cite_note-nlm-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="European_Union">European Union</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=6" title="Edit section: European Union"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the <a href="/wiki/European_Union" title="European Union">European Union</a>, the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.<sup id="cite_ref-ema_9-0" class="reference"><a href="#cite_note-ema-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=7" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/Clinical_research_associate" title="Clinical research associate">Clinical research associate</a></li> <li><a href="/wiki/Clinical_research_ethics" class="mw-redirect" title="Clinical research ethics">Clinical research ethics</a></li> <li><a href="/wiki/Clinical_trial_management_system" title="Clinical trial management system">Clinical trial management system</a></li> <li><a href="/wiki/Randomized_controlled_trial" title="Randomized controlled trial">Randomized controlled trial</a></li> <li><a href="/wiki/Evidence-based_medicine" title="Evidence-based medicine">Evidence-based medicine</a></li> <li><a href="/wiki/Unethical_human_experimentation" title="Unethical human experimentation">Unethical human experimentation</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Clinical_research&action=edit&section=8" 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"> <div class="mw-references-wrap"><ol class="references"> <li id="cite_note-nlm-1"><span class="mw-cite-backlink">^ <a href="#cite_ref-nlm_1-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-nlm_1-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-nlm_1-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-nlm_1-3"><sup><i><b>d</b></i></sup></a> <a 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a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://clinicaltrials.gov/study-basics/learn-about-studies">"Learn about studies"</a>. ClinicalTrials.gov, National Library of Medicine, US National Institutes of Health. 24 May 2023<span class="reference-accessdate">. Retrieved <span class="nowrap">9 March</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Learn+about+studies&rft.pub=ClinicalTrials.gov%2C+National+Library+of+Medicine%2C+US+National+Institutes+of+Health&rft.date=2023-05-24&rft_id=https%3A%2F%2Fclinicaltrials.gov%2Fstudy-basics%2Flearn-about-studies&rfr_id=info%3Asid%2Fen.wikipedia.org%3AClinical+research" class="Z3988"></span></span> </li> <li id="cite_note-nia-2"><span class="mw-cite-backlink">^ <a href="#cite_ref-nia_2-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-nia_2-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-nia_2-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-nia_2-3"><sup><i><b>d</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies">"What Are Clinical Trials and Studies?"</a>. 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0.25em"> <ul><li><a href="/wiki/Cross-sectional_study" title="Cross-sectional study">Cross-sectional study</a> vs. <a href="/wiki/Longitudinal_study" title="Longitudinal study">Longitudinal study</a>, <a href="/wiki/Ecological_study" title="Ecological study">Ecological study</a></li> <li><a href="/wiki/Cohort_study" title="Cohort study">Cohort study</a> <ul><li><a href="/wiki/Retrospective_cohort_study" title="Retrospective cohort study">Retrospective</a></li> <li><a href="/wiki/Prospective_cohort_study" title="Prospective cohort study">Prospective</a></li></ul></li> <li><a href="/wiki/Case%E2%80%93control_study" title="Case–control study">Case–control study</a> (<a href="/wiki/Nested_case%E2%80%93control_study" title="Nested case–control study">Nested case–control study</a>)</li> <li><a href="/wiki/Case_series" title="Case series">Case series</a></li> <li><a href="/wiki/Case_study" title="Case study">Case study</a></li> <li><a href="/wiki/Case_report" title="Case report">Case report</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Outcome_measure" title="Outcome measure">Measures</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Measures_of_occurrence" class="mw-redirect" title="Epidemiological methods">Occurrence</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Incidence_(epidemiology)" title="Incidence (epidemiology)">Incidence</a>, <a href="/wiki/Cumulative_incidence" class="mw-redirect" title="Cumulative incidence">Cumulative incidence</a>, <a href="/wiki/Prevalence" title="Prevalence">Prevalence</a>, <a href="/wiki/Point_prevalence" class="mw-redirect" title="Point prevalence">Point prevalence</a>, <a href="/wiki/Period_prevalence" class="mw-redirect" title="Period prevalence">Period prevalence</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Measures_of_association" class="mw-redirect" title="Epidemiological methods">Association</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Risk_difference" title="Risk difference">Risk difference</a>, <a href="/wiki/Number_needed_to_treat" title="Number needed to treat">Number needed to treat</a>, <a href="/wiki/Number_needed_to_harm" title="Number needed to harm">Number needed to harm</a>, <a href="/wiki/Risk_ratio" class="mw-redirect" title="Risk ratio">Risk ratio</a>, <a href="/wiki/Relative_risk_reduction" title="Relative risk reduction">Relative risk reduction</a>, <a href="/wiki/Odds_ratio" title="Odds ratio">Odds ratio</a>, <a href="/wiki/Hazard_ratio" title="Hazard ratio">Hazard ratio</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Population_impact_measure" title="Population impact measure">Population impact</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Attributable_fraction_among_the_exposed" title="Attributable fraction among the exposed">Attributable fraction among the exposed</a>, <a href="/wiki/Attributable_fraction_for_the_population" title="Attributable fraction for the population">Attributable fraction for the population</a>, <a href="/wiki/Preventable_fraction_among_the_unexposed" title="Preventable fraction among the unexposed">Preventable fraction among the unexposed</a>, <a href="/wiki/Preventable_fraction_for_the_population" title="Preventable fraction for the population">Preventable fraction for the population</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Epidemiological_methods#Other_measures" class="mw-redirect" title="Epidemiological methods">Other</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Clinical_endpoint" title="Clinical endpoint">Clinical endpoint</a>, <a href="/wiki/Virulence" title="Virulence">Virulence</a>, <a href="/wiki/Infectivity" title="Infectivity">Infectivity</a>, <a href="/wiki/Mortality_rate" title="Mortality rate">Mortality rate</a>, <a href="/wiki/Morbidity" class="mw-redirect" title="Morbidity">Morbidity</a>, <a href="/wiki/Case_fatality_rate" title="Case fatality rate">Case fatality rate</a>, <a href="/wiki/Specificity_and_sensitivity" class="mw-redirect" title="Specificity and sensitivity">Specificity and sensitivity</a>, <a href="/wiki/Likelihood_ratios_in_diagnostic_testing" title="Likelihood ratios in diagnostic testing">Likelihood-ratios</a>, <a href="/wiki/Pre-_and_post-test_probability" title="Pre- and post-test probability">Pre- and post-test probability</a></div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Trial/test types</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/In_vitro" title="In vitro">In vitro</a></li> <li><a href="/wiki/In_vivo" title="In vivo">In vivo</a></li> <li><a href="/wiki/Animal_testing" title="Animal testing">Animal testing</a></li> <li><a href="/wiki/Animal_testing_on_non-human_primates" title="Animal testing on non-human primates">Animal testing on non-human primates</a></li> <li><a href="/wiki/First-in-man_study" class="mw-redirect" title="First-in-man study">First-in-man study</a></li> <li><a href="/wiki/Multicenter_trial" title="Multicenter trial">Multicenter trial</a></li> <li><a href="/wiki/Seeding_trial" title="Seeding trial">Seeding trial</a></li> <li><a href="/wiki/Vaccine_trial" title="Vaccine trial">Vaccine trial</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Analysis_of_clinical_trials" title="Analysis of clinical trials">Analysis of clinical trials</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Risk%E2%80%93benefit_ratio" title="Risk–benefit ratio">Risk–benefit ratio</a></li> <li><a href="/wiki/Systematic_review" title="Systematic review">Systematic review</a></li> <li><a href="/wiki/Reproducibility" title="Reproducibility">Replication</a></li> <li><a href="/wiki/Meta-analysis" title="Meta-analysis">Meta-analysis</a></li> <li><a href="/wiki/Intention-to-treat_analysis" title="Intention-to-treat analysis">Intention-to-treat analysis</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Interpretation of results</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Selection_bias" title="Selection bias">Selection bias</a></li> <li><a href="/wiki/Survivorship_bias" title="Survivorship bias">Survivorship bias</a></li> <li><a href="/wiki/Correlation_does_not_imply_causation" title="Correlation does not imply causation">Correlation does not imply causation</a></li> <li><a href="/wiki/Null_result" title="Null result">Null result</a></li> <li><a href="/wiki/Sex_as_a_biological_variable" title="Sex as a biological variable">Sex as a biological variable</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div> <ul><li><b><a href="/wiki/Category:Clinical_research" title="Category:Clinical research">Category</a></b></li> <li><b><a href="/wiki/Glossary_of_clinical_research" title="Glossary of clinical research">Glossary</a></b></li> <li><b><a href="/wiki/List_of_clinical_research_topics" class="mw-redirect" title="List of clinical research topics">List of topics</a></b></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="Research_participant_rights" style="padding:3px"><table class="nowraplinks mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Research_participant_rights" title="Template:Research participant rights"><abbr title="View this 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<li><a href="/wiki/Respect_for_persons" title="Respect for persons">Respect for persons</a></li> <li><a href="/wiki/Privacy_for_research_participants" title="Privacy for research participants">Privacy for research participants</a></li> <li><a href="/wiki/Right_to_withdraw" title="Right to withdraw">Right to withdraw</a></li> <li><a href="/wiki/Return_of_results" title="Return of results">Return of results</a></li> <li><a href="/wiki/Informed_consent" title="Informed consent">Informed consent</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Human_subject_research" title="Human subject research">Human subject research</a></th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a class="mw-selflink selflink">Clinical research</a></li> <li><a href="/wiki/Biobank" title="Biobank">Biobank</a></li> <li><a href="/wiki/Social_research" title="Social 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