06 Sep Diversity Action Plans for Clinical Trials: Evaluating FDA’s Draft Guidance

By Arthur Lazarus, MD, MBA, and LaQuinta Jernigan, Medpage Today

The FDA is intent on improving the enrollment of participants — also known as “subjects” — from underrepresented populations in clinical studies for drugs and devices. The FDA’s initiative is not unlike the attempts of institutions of higher learning to increase student diversity through diversity, equity, and inclusion (DEI) programs. The FDA has issued a draft guidance for sponsors — mainly the pharmaceutical industry — entitled “Diversity Action Plans [DAPs] to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” After a formal commenting period set to end September 26, 2024, the guidance will become official, pending revisions.

Clinical studies assess the safety and efficacy of drugs and devices designed for preventing, treating, or diagnosing various conditions and diseases. In the U.S., certain populations are often underrepresented in biomedical research despite bearing a disproportionate burden of specific conditions. This underrepresentation stems from multiple factors, such as assumptions about the feasibility of enrolling a representative population and the potential impact on study timelines, as well as the absence of a proactive strategy to ensure the enrollment and retention of a study population that mirrors the intended use population. Read more…