Guest Column | June 27, 2024

What's Lacking In FDA's Latest Diversity Guidance?

By Denise Bronner, Ph.D.

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Denise Bronner Ph.D.

Hot off the press, the FDA released a new guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This is a monumental step for the pharma industry to ensure trial populations reflect the real world. There are several changes compared to the previous guidance (e.g., expansion to include other underrepresented communities, operational measures to enroll & retain); however, there are a few key areas where the guidance falls short:

Loose Criteria for Waivers: There is flexibility in granting waivers (case-by-case basis), thus, it could undermine efforts to ensure diversity if not strictly regulated.

Limited Scope on Other Underrepresented Groups: Main focus is on race, ethnicity, sex, and age. The guidance does acknowledge other underrepresented groups like those based on geographic location, socioeconomic status, or disability, however they are not prioritized to the same extent as the main demographic categories.

Global Considerations: The guidance does state that global studies should be designed with appropriate considerations and that multinational studies should have a DAP (diversity action plan) for the entire study and not limited to the U.S. only. However, it lacks clear strategies for integrating global data because diversity means different things to different countries/regions.

Non-binding Nature: The guidance is non-binding, potentially reducing its impact on ensuring consistent application across clinical trials.

No Consequences for Not Meeting Goals: The guidance does not specify consequences if DEI goals are not met, potentially reducing accountability. Although reporting is required, it is unclear what the threshold of missing DEI goals would be, if PMRs (postmarketing requirements) will be required, or if approvals will be impacted if DEI goals are not achieved.

Limited Scope to Phase III: Despite acknowledging the importance of diversity in earlier phases, the guidance focuses mainly on Phase 3 trials, and mentions that pharmacokinetic data should be shared without mandating earlier diversity inclusion.

The new FDA guidance on diversity in clinical trials is a promising development toward inclusivity in medical research. By acknowledging a broader spectrum of underrepresented groups and extending the scope to global studies, the guidance sets a foundation for more equitable clinical practices. Moving forward, enhancing the enforceability of these guidelines and broadening their application to earlier trial phases could significantly strengthen their impact. It is hopeful that with these advancements, clinical trials will not only become more diverse but also more reflective of all populations they aim to serve.

Would love to hear other people's thoughts on this. Are there other areas that were not covered that need to be addressed?

Denise N Bronner, Ph.D. has roughly 15 years of organizational thought leadership experience within the global healthcare/tech space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within the pharma space. Beyond her professional endeavors, she's passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a Bachelor’s degree in Biological Sciences from Wayne State University, a Ph.D. in Microbiology & Immunology from the University of Michigan - Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.