FDA Calls for Increased Clinical Trial Diversity

It’s time for the clinical trials industry to step up to the plate and do everything it can to champion diversity in clinical trial participants, says Jonca Bull, MD, Assistant Commissioner for Minority Health with the Office of Minority Health in the U.S. Food and Drug Administration (FDA). “Participants need to more closely mirror the patients who will ultimately use the medicine.”

A number of diseases impact some populations in different manners than others. For example, sickle cell disease primarily affects people of African and Hispanic descent, and Asian American communities report more hepatitis B. Currently, however, the majority of clinical trial participants are white and male.

Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials, says FDA Commissioner Robert Califf, MD. He cites a wide range of literature that has recorded this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials.

The result? “We may miss vital data that could be used to…make better evidence-based, regulatory decisions,” suggests Bull.

Last month, the FDA launched a new diversity awareness program to coincide with World Sickle Cell Day (June 19), observed annually to help increase public knowledge and raise awareness of sickle cell disease.

Learn More

For more on FDA’s “The Year of Clinical Trial Diversity” initiative, visit FDA’s Blog.