Diversity In Clinical Trials: FDA Draft Guidance On Diversity Action Plan Requirements

By Ashni Parekh, Global Compliance and Strategy Analyst, Medidata

Under the Federal Drug and Omnibus Reform Act (FDORA), the FDA recently introduced a draft guideline titled "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials." This guideline mandates a Diversity Action Plan (DAP) for late-stage trial protocol submissions. The DAP ensures that trial enrollment mirrors the diversity of the affected population, taking into account variables such as age, sex, race, ethnicity, and socioeconomic status. It includes strategies like community engagement and language assistance to achieve these goals. In this text, we review how DAP is vital for producing representative and applicable trial results, particularly for diseases that disproportionately impact diverse groups.