As the executive vice president of Health at the Milken Institute, I was very excited to see the new guidance from the FDA requiring drug and medical device sponsors to submit Diversity Action Plans as part of their submission of Phase 3 clinical trial or pivotal study protocol. This is a significant step toward creating more diverse and inclusive clinical trials.
The lessons from the COVID-19 pandemic made it abundantly clear that we must increase diversity and inclusion in clinical research to better reflect the demographics and disease burden in the United States. For too long, clinical trials have disproportionately enrolled patients from narrow sets of populations and have not captured all US intended populations across different racial/ethnic groups, sexes, ages, geographies, etc.
The latest FDA guidance puts some teeth behind the agency’s prior recommendations of the Diversity Action Plans by implementing the mandate defined by the Food and Drug Omnibus Act (FDORA). The pharmaceutical industry must now detail the disease prevalence data, patient characteristics, and specific strategies for targeting underrepresented groups at U.S. clinical trial sites. It’s no longer just a nice-to-have – there are now regulatory implications for not prioritizing diversity.
Based on this guidance, companies should focus on these key elements:
- Enabling clinical trial enrollment at a diverse, expanded range of sites that serve diverse patient populations, in addition to traditional academic medical centers.
- Building out new trial site infrastructure and workforce in underserved areas with high disease burdens.
- Partnering with community organizations, promoters, and trusted local messengers to raise awareness and establish long-term relationships, not just short-term “helicopter” outreach.
- Shifting the focus away from a top-down approach to a true collaboration with communities to understand their needs and priorities first and involve them throughout the research.
- Examine the clinical trial design to ensure the protocol facilitates enrollment of diverse populations relevant to the study question and disease burden.
Undoubtedly, this will require a significant cultural shift for drugmakers and a real investment in building sustainable clinical trial capabilities in new locations. But it’s a shift that is long overdue. We cannot continue to develop drugs and medical devices without understanding their real-world impacts across all patient groups.
I’m encouraged that with this FDA mandate, the industry will finally allocate the necessary resources and attention to improving diversity in clinical trials. It’s not just about checking a box but about ensuring we have safe and effective treatments and medical products that work for everyone. The FDA has provided a clear framework, and now it’s on sponsors to deliver robust Diversity Action Plans backed by investment on the ground. Representation won’t improve overnight, but this guidance is a crucial step in the right direction.
Esther Krofah is the executive vice president of MI Health, leading FasterCures, Public Health, the Future of Aging, and Feeding Change. She has deep experience in the government, nonprofit, and for-profit sectors, where she has led efforts to bring together diverse stakeholder groups to solve critical issues and achieve shared goals that improve the lives of patients.
