FDA: Clinical Trial Diversity


Clinical trials are research studies involving human volunteers to evaluate medical products like medications, vaccines, or devices for safety and effectiveness. These studies may also show which medical products or therapies work best for people with certain illnesses or for certain groups of people. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity.

5 things you should know about clinical trials

  1. Clinical trials are research studies conducted with people—they are designed to answer specific research questions about medical products or therapies.
  2. Participation is always voluntary—you can leave a study whenever you want.
  3. Clinical trials often need healthy volunteers to help answer research questions.
  4. Your safety is a priority. Researchers must follow detailed protocols and the FDA’s safety requirements to make each trial as safe as possible.
  5. The study will be explained to you in an informed consent process before you agree to join.

The importance of diverse participation in clinical trials

Participants in clinical trials should represent the patients that will use the medical products. This is often not the case—people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to medical products. To achieve health equity so all can benefit from clinical trials, we are committed to taking steps to change this.

Joining a clinical trial might be a good choice for you if:

  • You and your health care provider believe a clinical trial may provide another option when standard treatments have failed.
  • You want to help test new medical products or therapies in the diverse patients likely to use them.
  • You want to help researchers find better ways to fight diseases.

Learn more

If you think a clinical trial may be right for you, talk to your health care provider. You can also search for clinical trials in your area at www.ClinicalTrials.gov. To watch videos and view a list of questions to ask researchers, visit www.hhs.gov/about-research-participation.

To obtain concise information about who participated in clinical trials that supported the FDA approval of new drugs, visit Drug Trials Snapshots at www.fda.gov/drugtrialssnapshot.

For more information on health equity, visit www.fda.gov/healthequity.

Source: https://www.fda.gov/consumers/minority-health-and-health-equity-resources/clinical-trial-diversity