Clinical Trial Diversity From A Disclosure Perspective

Diversity in clinical trials has become a critical focus, especially with the FDA’s updated diversity plan guidance. Fenwick Eckhardt of Citeline Consulting outlined five key criteria that sponsors must report on, including disease overview, product development plans, enrollment goals, and retention strategies for underrepresented groups. However, challenges persist, such as the lack of harmonization between FDA guidelines and global or federal reporting standards on race and ethnicity. Additionally, age and other demographics like LGBTQIA+ populations and people with disabilities require more nuanced approaches.

Eckhardt and Sylvia Baedorf Kassis from the Multi-Regional Clinical Trials Center emphasized the importance of incorporating real-world data and social determinants of health into trial designs to address access and equity issues. Clear, plain-language communication is also crucial for building trust with underrepresented populations. As the FDA's mandate takes full effect in 2025, sponsors are encouraged to take proactive steps now to meet and exceed diversity expectations in clinical trials.