TOTAL Diversity Blog

Navigating the Future of Diversity in Clinical Trials: Insights into FDA’s FDORA Mandate The landscape of clinical trials is evolving, with diversity at the forefront of this shift. On June 26, 2024, the FDA released draft guidance on the Food and Drug Omnibus Reform Act (FDORA), setting new expectations for inclusivity in pivotal studies. This marks a significant step toward ensuring clinical trials reflect the diverse populations that will ultimately use the treatments. With the full enactment of FDORA just months away, sponsors need to start thinking about how they will meet these requirements. At the heart of the guidance is the Diversity Action Plan (DAP), which outlines how sponsors will incorporate diversity into each trial. The key question now is: Is your organization ready? Broadening the Definition of Diversity in Clinical Trials One of the most impactful changes in the FDA’s draft guidance is its expanded view of diversity. While clinical trial diversity has traditionally focused on race and ethnicity, the new guidelines extend the definition to include factors such as geography, socioeconomic status, gender, comorbidities, and pregnancy status. Recruitment and retention of participants from underrepresented communities is also a central focus. Building trust and engaging these communities can be challenging but is necessary to achieve meaningful diversity that will make trial results more robust and applicable. Operationalizing the Diversity Action Plan The FDA guidance provides a clear structure for how sponsors should create and submit DAPs. It emphasizes the need for detailed descriptions of how underrepresented populations will be enrolled and retained in clinical trials. This is a critical shift that requires thoughtful planning and execution. For sponsors seeking waivers from these diversity requirements, the guidance now includes a more defined process for evaluating waiver requests. This clarity gives organizations a better understanding of how to proceed if they face challenges in meeting diversity targets. FDA Commissioner Robert M. Califf, M.D., shared: “Participants in clinical trials should be representative of the patients who will use the medical products.” This reflects the FDA’s ongoing efforts to enhance the diversity of trial participants and improve the relevance of trial data. Why This Matters Diversity in clinical trials is not just a regulatory requirement—it’s a critical step toward improving patient outcomes for all. When trial participants reflect the diversity of the real-world population, the data becomes more reliable and the treatments more effective across different patient groups. The FDA’s new guidance is a necessary move toward this goal, but it will require sponsors to rethink their current practices. From refining recruitment strategies to ensuring comprehensive data collection processes, organizations will need to develop robust plans for achieving these new standards. As the industry transitions toward a more inclusive approach, sponsors must evaluate their readiness to meet the FDA’s requirements. How TOTAL Diversity is Equipped to Help At TOTAL Diversity Clinical Trial Management, diversity is at the core of our mission. For over a decade, we’ve ensured clinical trials are inclusive, with expertise in areas like neurology and rare diseases. As the only full-service Clinical Research Organization (CRO) with dedicated diversity services, we’re uniquely equipped to help sponsors meet the FDA’s new requirements. With deep experience in developing Diversity Action Plans, navigating FDA feedback, and executing community engagement strategies, we provide the support you need to succeed. Ready to meet the FDA’s diversity standards? TOTAL can guide you through the process and ensure your trials make a meaningful impact.