The FDA’s draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines the agency’s expectations for sponsors of clinical studies involving drugs, biological products, and devices. The primary goal of this guidance is to enhance the inclusion of underrepresented populations in clinical research, ensuring that study findings are more generalizable and relevant to diverse groups.
The guidance assists sponsors in developing Diversity Action Plans (DAPs) required under sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Omnibus Reform Act of 2022. DAPs must set specific enrollment targets disaggregated by race, ethnicity, sex, and age, and align with FDA guidelines for demographic reporting. Sponsors are required to provide a detailed rationale for their enrollment goals, explaining the scientific and clinical justifications for these targets. They must also outline strategies and actions to meet these goals, which may include community engagement, partnerships with local healthcare providers, and culturally tailored recruitment materials.
The guidance details timelines for submitting DAPs, procedures for receiving FDA feedback, and the process for requesting waivers if needed. It highlights the importance of early and ongoing communication between sponsors and the FDA to ensure the effectiveness of the diversity plans. Sponsors are encouraged to publicly post key DAP information to enhance transparency and accountability. Additionally, the guidance provides a framework for updating DAPs based on recruitment progress and emerging data.
Overall, the FDA’s draft guidance emphasizes the critical role of diversity in clinical trials to ensure that the benefits and risks of medical products are assessed across varied populations, ultimately aiming to improve public health outcomes.
Read the full guidance here.
