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Minorities in Clinical Trials Fact Sheet

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What is a clinical trial?

Clinical trials are research studies that determine whether medical products like medicines, vaccines, or devices are safe and effective. These studies may show which medical approaches work best for certain illnesses or groups of people.

4 things you should know about clinical trials

  1. Clinical trials are research studies conducted with peoplethey are designed to answer specific research questions about medical products or procedures. Researchers must follow detailed protocols and the FDA’s safety guidelines to make each trial as safe as possible.
  2. Participation is always voluntary—and you can leave a study whenever you want.
  3. Clinical trials often need healthy volunteers to help answer their research questions.
  4. FDA does not conduct clinical trialsFDA works with companies that develop medical products to protect participants and review the results to ensure that the medical product is safe and effective.

The importance of minority participation in clinical trials

Participants in clinical trials should represent the patients that will use the medical products. This is often not the case--racial and ethnic minorities are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities, may react differently to medical products. We are committed to working with companies to change this. Joining a clinical trial might be a good choice for you if:

  • You and your doctor believe current treatments aren’t good options and a clinical trial offers additional alternatives.
  • You want to help ensure that the benefits and risks of new medical products are studied in the range of patients likely to need them.
  • You want to help researchers find better ways to fight diseases.

If you think a clinical trial may be right for you, talk to your doctor. You can also search for clinical trials on an online database, www.ClinicalTrials.gov.

If you want to know more about a recently approved drug you may be taking, visit the Drug Trials Snapshots—a database that gives you information on who participated in a trial for recent drug approvals. You can find more information at www.FDA.gov/DrugTrialsSnapshot.

For more information on minority health go to www.fda.gov/healthequity. To watch videos and view a list of questions to ask researchers go to www.hhs.gov/about-research-participation.

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