Diversity in Clinical Trials, New FDA Guidance


In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials.

According to its Drug Trials Snapshots Report for 2019, of the clinical trials supporting the approvals of the 48 novel drugs the Food and Drug Administratio (FDA) approved in 2019, just 9 percent of the participants were Black, 9 percent Asian, and 18 percent Hispanic.

With the aim of improving diversity in clinical trials, the FDA recently announced the availability of draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”  Expanding on 2016 directives, the purpose of this new guidance is to provide recommendations on the approach to developing a Race and Ethnicity Diversity Plan to enroll enough participants in clinical trials from underrepresented racial and ethnic populations.

Since the pandemic widely exposed health inequities in the United States, innovators have also taken an interest in diversifying clinical trials as a component of addressing that inequity. In a recent PharmaBoardroom interview, Stephen J. Ubl, President & CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) said: “An improvement in clinical trial diversity is crucial in rebuilding trust in communities of color that have historically been excluded from data collection efforts and mistreated in trials.”

The new guidance focuses specifically on racial and ethnic minorities, however, the FDA advises clinical trial sponsors to seek diversity with respect to other demographic factors like sex, gender identity, age, pregnancy, and the presence of clinical characteristics such as multiple comorbidities.

“The US population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert Califf, MD in a statement.

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