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.
The FDA’s draft guidance was developed by the Oncology Center of Excellence’s Project Equity, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. To support the FDA’s efforts, the Office of Minority Health and Health Equity developed the “Diversity in Clinical Trials Initiative,” which includes a public education and outreach campaign to address some of the barriers with culturally and linguistically tailored strategies and resources.
The FDA’s new draft guidance aligns with the goals of Cancer Moonshot, a federal oncology program from 2016 that President Joe Biden relaunched this February and aims to address inequities in access to cancer screening, diagnostics and treatment.
“The U.S. 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,” FDA Commissioner Robert Califf, M.D., said in an April 13 news release. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”