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• Summary
• Start Here

Learn More

• Related Issues
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Summary

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.

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.

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:

• Make sure that the study is ethical
• Protect the rights and welfare of the participants
• Make sure that the risks are reasonable when compared to the potential benefits

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.

NIH: National Institutes of Health

Start Here

• Clinical Research FAQ (National Human Genome Research Institute)
• Clinical Trial Basics (National Institutes of Health)
• How Clinical Trials Work (National Heart, Lung, and Blood Institute)

Related Issues

• Are Clinical Trials Safe? (National Cancer Institute) Also in Spanish
• Who Pays for Clinical Trials? (National Cancer Institute)

Specifics

• About Cancer Clinical Research (National Cancer Institute) Also in Spanish
• Are Clinical Studies for You? (National Institutes of Health, Clinical Center) Also in Spanish
• Cancer Clinical Trials at the National Institutes of Health Clinical Center (National Cancer Institute) Also in Spanish
• Clinical Trials -- Information for Participants (National Institute of Mental Health) Also in Spanish
• Clinical Trials: Benefits, Risks, and Safety (National Institute on Aging)
• NCI's Clinical Trials Programs and Initiatives (National Cancer Institute) Also in Spanish
• Participating in Alzheimer's Disease and Related Dementias Research (National Institute on Aging)
• Volunteer Stories (National Institutes of Health)
• Will I Always Get the Experimental Treatment in a Clinical Trial? (National Institute on Aging)

Videos and Tutorials

• Should I Participate in a Clinical Trial? What's in It for Me? (National Institutes of Health)
• What Is a Clinical Trial? (National Institutes of Health) Also in Spanish

Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)

• Article: Japan's Perspective on Facilitating Drug Development Through Asian Cooperation in Multi-Regional...
• Article: Testing for Similarity of Dose Response in Multiregional Clinical Trials.
• Article: Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical...
• Clinical Trials -- see more articles

Reference Desk

• ClinicalTrials.gov Glossary Terms (National Institutes of Health)

Find an Expert

• ClinicalTrials.gov Background Information (National Institutes of Health)
• ClinicalTrials.gov: Search Clinical Trials (National Institutes of Health)
• National Institutes of Health

Children

• Children's Assent to Clinical Trial Participation (National Cancer Institute)
• Should Your Child Participate in a Clinical Trial? (Food and Drug Administration) Also in Spanish

Women

• Women in Clinical Trials (Food and Drug Administration)

Patient Handouts

• A guide to clinical trials for cancer (Medical Encyclopedia) Also in Spanish