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Diversity in Clinical Trials

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

Clinical trials are research studies conducted with people—they 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.

Participation is always voluntary—and you can leave a study whenever you want.

Clinical trials often need healthy volunteers to help answer their research questions.

FDA does not conduct clinical trials—FDA 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.

Increasing diversity in clinical trials: What can doctors, regulators, and patients do?

Most clinical trials do not score highly on the diversity front. In this Special Feature, we explore who takes part in clinical trials, what barriers prevent others from doing so, and what patients, doctors, and those involved in drug approvals can do to improve on this.

Many diseases lack effective treatments, and many researchers worldwide are trying to address these unmet needs.

Clinical trials form the cornerstone of new drug approvals, and without the volunteers who participate in clinical trials, this process would not be possible.

Yet, clinical trials overwhelmingly fail to represent the demographic diversity of the populations that the drugs in development aim to serve.

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