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Clinical Trials
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<h3>Basics</h3>
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<a title="Go to: Start Here" href="#cat_51">Start Here</a>
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<h3>Learn More</h3>
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<a title="Go to: Related Issues" href="#cat_47">Related Issues</a>
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<li>
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<a title="Go to: Specifics" href="#cat_42">Specifics</a>
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<h3>See, Play and Learn</h3>
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<a title="Go to: Videos and Tutorials" href="#cat_94">Videos and Tutorials</a>
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<h3>Research</h3>
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<a title="Go to: Journal Articles" href="#cat_59">Journal Articles</a>
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<h3>Resources</h3>
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<a title="Go to: Reference Desk" href="#cat_82">Reference Desk</a>
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<a title="Go to: Find an Expert" href="#cat_83">Find an Expert</a>
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<h3>For You</h3>
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<a title="Go to: Children" href="#cat_8">Children</a>
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<a title="Go to: Women" href="#cat_7">Women</a>
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<li>
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<a title="Go to: Patient Handouts" href="#cat_69">Patient Handouts</a>
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</section>
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<a name="summary"></a>
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<section id="topsum_section">
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<div class="summary-title syndicate">
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<h2>Summary</h2>
|
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</div>
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||
<div id="topic-summary" class="syndicate"><p>Clinical trials are research studies that test how well new medical approaches work in people. Each study
|
||
answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a
|
||
disease. Clinical trials may also compare a new treatment to a treatment that is already available.</p>
|
||
|
||
<p>Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what
|
||
will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study
|
||
has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need
|
||
healthy people. Others want just men or just women.</p>
|
||
|
||
<p>An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to:</p><ul>
|
||
<li>Make sure that the study is ethical</li>
|
||
<li>Protect the rights and welfare of the participants</li>
|
||
<li>Make sure that the risks are reasonable when compared to the potential benefits</li>
|
||
</ul>
|
||
|
||
<p>In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.</p>
|
||
|
||
<p class="attribution">NIH: National Institutes of Health</p></div>
|
||
|
||
</section>
|
||
|
||
|
||
|
||
|
||
|
||
<a name="cat_51"></a>
|
||
<section id="cat_51_section">
|
||
<div class="section">
|
||
<div class="section-header expanded">
|
||
<div class="section-title syndicate">
|
||
<h2>Start Here
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section51" class="section-body expanded syndicate" aria-expanded="true">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.genome.gov/FAQ/Clinical-Research" target="TheNewWin" data-sid="34142" data-org="NHGRI">Clinical Research FAQ</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Human Genome Research Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics" target="TheNewWin" data-sid="77373" data-org="NIH">Clinical Trial Basics</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institutes of Health)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nhlbi.nih.gov/research/clinical-trials/how-studies-work" target="TheNewWin" data-sid="117268" data-org="NHLBI">How Clinical Trials Work</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<img width="20" height="16" alt="Video" title="Video" src="https://medlineplus.gov/images/videocamera.gif" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Heart, Lung, and Blood Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<a name="cat_47"></a>
|
||
<section id="cat_47_section">
|
||
<div class="section">
|
||
<div class="section-header">
|
||
<div class="section-title">
|
||
<h2>Related Issues
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section47" class="section-body">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.cancer.gov/research/participate/clinical-trials/safety#informed-consent" target="TheNewWin" data-sid="10534" data-org="NCI">Are Clinical Trials Safe?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Cancer Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
<span class="also-lang"> Also in <a target="TheNewWin2" href="https://www.cancer.gov/espanol/investigacion/participe/estudios-clinicos/son-seguros-los-estudios-clinicos" data-sid="119748">Spanish</a> </span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.fda.gov/consumers/minority-health-and-health-equity-resources/clinical-trial-diversity" target="TheNewWin" data-sid="109308" >Clinical Trial Diversity</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<span class="orgs"> (Food and Drug Administration)</span>
|
||
|
||
|
||
</span>
|
||
|
||
<span class="also-lang"> Also in <a target="TheNewWin2" href="https://www.fda.gov/consumers/minority-health-and-health-equity-resources/diversidad-en-los-estudios-clinicos-hoja-informativa" data-sid="119599">Spanish</a> </span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.cancer.gov/research/participate/clinical-trials/paying" target="TheNewWin" data-sid="159666" data-org="NCI">Who Pays for Clinical Trials?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Cancer Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
|
||
|
||
<a name="cat_42"></a>
|
||
<section id="cat_42_section">
|
||
<div class="section">
|
||
<div class="section-header">
|
||
<div class="section-title">
|
||
<h2>Specifics
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section42" class="section-body">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.cancer.gov/research/participate/about-cancer-clinical-research" target="TheNewWin" data-sid="159668" data-org="NCI">About Cancer Clinical Research</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Cancer Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.cc.nih.gov/participate/studies" target="TheNewWin" data-sid="111443" data-org="NIHCC">Are Clinical Studies for You?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institutes of Health, Clinical Center)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.cancer.gov/about-cancer/treatment/clinical-center" target="TheNewWin" data-sid="128141" data-org="NCI">Cancer Clinical Trials at the National Institutes of Health Clinical Center</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Cancer Institute)</span>
|
||
|
||
|
||
</span>
|
||
|
||
<span class="also-lang"> Also in <a target="TheNewWin2" href="https://www.cancer.gov/espanol/cancer/tratamiento/centro-clinico" data-sid="128143">Spanish</a> </span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nimh.nih.gov/health/trials" target="TheNewWin" data-sid="74752" data-org="NIMH">Clinical Trials -- Information for Participants</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institute of Mental Health)</span>
|
||
|
||
|
||
</span>
|
||
|
||
<span class="also-lang"> Also in <a target="TheNewWin2" href="https://www.nimh.nih.gov/health/trials/estudios-clinicos-informacion-para-los-participantes" data-sid="112450">Spanish</a> </span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nia.nih.gov/health/clinical-trials-and-studies/clinical-research-benefits-risks-and-safety" target="TheNewWin" data-sid="132927" data-org="NIA">Clinical Trials: Benefits, Risks, and Safety</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institute on Aging)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nia.nih.gov/health/clinical-trials-and-studies/participating-alzheimers-disease-and-related-dementias-research" target="TheNewWin" data-sid="133110" data-org="NIA">Participating in Alzheimer's Disease and Related Dementias Research</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institute on Aging)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/personal-stories" target="TheNewWin" data-sid="77405" data-org="NIH">Volunteer Stories</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institutes of Health)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nia.nih.gov/health/clinical-trials-and-studies/clinical-research-benefits-risks-and-safety#treatment" target="TheNewWin" data-sid="117286" data-org="NIA">Will I Always Get the Experimental Treatment in a Clinical Trial?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institute on Aging)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<a name="cat_94"></a>
|
||
<section id="cat_94_section">
|
||
<div class="section">
|
||
<div class="section-header">
|
||
<div class="section-title">
|
||
<h2>Videos and Tutorials
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section94" class="section-body">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nlm.nih.gov/oet/ed/ceal/should-i-participate-in-a-clinical-trial.html" target="TheNewWin" data-sid="150569" data-org="NIH">Should I Participate in a Clinical Trial? What's in It for Me?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institutes of Health)</span>
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.nlm.nih.gov/oet/ed/ceal/what-is-a-clinical-trial.html" target="TheNewWin" data-sid="150568" data-org="NIH">What Is a Clinical Trial?</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
<img width="25" height="16" alt="From the National Institutes of Health" title="From the National Institutes of Health" src="https://medlineplus.gov/images/nih.png" class="imgdesc">
|
||
|
||
<span class="orgs"> (National Institutes of Health)</span>
|
||
|
||
|
||
</span>
|
||
|
||
<span class="also-lang"> Also in <a target="TheNewWin2" href="https://www.nlm.nih.gov/oet/ed/ceal/what-is-a-clinical-trial-spanish.html" data-sid="150587">Spanish</a> </span>
|
||
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<a name="cat_59"></a>
|
||
<section id="cat_59_section">
|
||
<div class="section">
|
||
<div class="section-header">
|
||
<div class="section-title">
|
||
<h2>Journal Articles
|
||
|
||
<span class="subheading">References and abstracts from MEDLINE/PubMed (National Library of Medicine)</span>
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section59" class="section-body">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.ncbi.nlm.nih.gov/pubmed/39829970" target="TheNewWin" data-sid="11004" >Article: Perceptions of Cardiovascular Healthcare Professionals Regarding Clinical Trials: A Survey-Based Study...</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.ncbi.nlm.nih.gov/pubmed/39806587" target="TheNewWin" data-sid="11004" >Article: Which clinical trial designs and statistical approaches have been used in...</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://www.ncbi.nlm.nih.gov/pubmed/39800465" target="TheNewWin" data-sid="11004" >Article: Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials.</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Clinical+Trials+as+Topic%22%5Bmajr%3Anoexp%5D+AND+humans%5Bmh%5D+AND+english%5Bla%5D+AND+%22last+2+Years%22+%5Bedat%5D+NOT+%28letter%5Bpt%5D+OR+case+reports%5Bpt%5D+OR+editorial%5Bpt%5D+OR+comment%5Bpt%5D%29+AND+free+full+text%5Bsb%5D+" target="TheNewWin" data-sid="11004" >Clinical Trials -- see more articles</a>
|
||
|
||
<span class="desc-text">
|
||
|
||
|
||
|
||
|
||
</span>
|
||
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<a name="cat_82"></a>
|
||
<section id="cat_82_section">
|
||
<div class="section">
|
||
<div class="section-header">
|
||
<div class="section-title">
|
||
<h2>Reference Desk
|
||
|
||
</h2>
|
||
</div>
|
||
<div class="section-button">
|
||
<button title="Expand/Collapse section" role="button" aria-controls="section" aria-pressed="true" type="submit">
|
||
<span class="icon icon-section-action"></span>
|
||
</button>
|
||
</div>
|
||
|
||
<div aria-live="polite" class="sm-live-area hide-offscreen"></div>
|
||
</div>
|
||
<div id="section82" class="section-body">
|
||
|
||
<ul class="bulletlist">
|
||
|
||
|
||
<li>
|
||
|
||
|
||
<a href="https://clinicaltrials.gov/ct2/about-studies/glossary" target="TheNewWin" data-sid="38446" data-org="NIH">ClinicalTrials.gov Glossary Terms</a>
|
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