FDA DEPICT Act and Sponsor Responsibilities in Clinical Trials

This document is a guide detailing the DEPICT Act (Diverse and Equitable Participation in Clinical Trials Act) passed by Congress in December 2022, which aims to enhance diversity in clinical trials. It outlines the responsibilities of clinical trial sponsors to submit Diversity Action Plans for Phase III or pivotal trials, including specific goals for participant enrollment and strategies to achieve these goals. The guide discusses the necessity for sponsors to provide a rationale for their enrollment goals and the importance of engaging under-represented populations, including racial and ethnic minorities, older adults, and LGBTQ+ individuals. It emphasizes the need for transparency and community engagement to build trust, as well as the potential challenges sponsors may face. Recommendations for improving diversity in clinical trials are also provided, including the importance of having diverse research teams and utilizing community leaders to foster inclusivity. Future guidance from the FDA regarding the content of Diversity Action Plans is anticipated.