The U.S. Food and Drug Administration (FDA) has issued draft guidance to drugmakers and medical device manufacturers to enhance racial, ethnic, and demographic diversity in clinical trials. The guidance outlines strategies for setting and meeting goals for study enrollment, segmented by age, ethnicity, sex, and race.
The primary objective is to better reflect the composition of patient populations in clinical trials, especially addressing the historically lower participation rates among certain groups, such as Black Americans, who experience higher rates of certain diseases. The FDA emphasized that study goals, or “diversity action plans,” should consider the estimated prevalence of the disease being evaluated.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, stated that these plans are intended to ensure sponsors consider the diverse characteristics of the patient population when designing clinical studies. Although the guidance is not legally binding, it is generally adhered to by companies seeking FDA approval for their products.
Under the 2022 Food and Drug Omnibus Reform Act, the FDA will now require companies to submit plans detailing how they intend to increase diversity in studies of most new drugs and medical devices. The guidance also includes criteria and processes for the FDA to evaluate requests from manufacturers who may be unable to declare their diversity goals.
As reported by Reuters, the FDA suggests improving access to clinical trials by starting studies in geographically diverse areas. The agency is seeking public comments on the draft guidance for 90 days before finalizing it. All studies beginning enrollment within six months after the final guidelines are published will need to comply with these new requirements.