FDA urges creation of racial, ethnic recruitment plans for clinical trials


By Gabrielle Masson

Apr 14, 2022, 3:15pm


The FDA is encouraging drugmakers to create and submit racial and ethnic recruitment plans for clinical trials early in the drug development process in an effort to boost participation among underrepresented populations.


Sponsors of medical products are now advised to develop and submit a “Race and Ethnicity Diversity Plan,” which spells out diverse participant enrollment and retention processes, to the FDA early in clinical development, according to a framework outlined in the new guidance.

The new recommendations—titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials”—expound upon the FDA’s prior guidance released at the end of 2021 to increase clinical trial diversity.


Black Americans make up 13% of the population but 5% of clinical trials, according to a recent report from life science consulting firm Trinity Life Sciences. The gap is even worse for Hispanic or Latino Americans, who account for 19% of the U.S. population but make up roughly 1% of clinical trial participants. The firm called on the FDA last month to implement minimum representation requirements for clinical trials to boost diversity.


Trinity report authors urged the FDA to come up with enrollment requirements that take racial demographics of specific diseases under consideration when working on a related clinical trial.

The FDA's new guidance does not impose any requirements on companies, including any minimum enrollment standards for underserved populations.


Racial and ethnic minorities are often underrepresented in biomedical research despite having a disproportionate burden for many diseases. This means that clinical trial enrollment may not accurately reflect the diversity of the population that will ultimately receive approved treatments. Barriers to participation among racial and ethnic groups are many, including mistrust of the system due to historical abuses; inadequate recruitment and retention efforts; frequency of study visits; time and resource constraints; transportation and scheduling conflicts; and language and cultural differences, among others.


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