2024 - Navigating FDA’s Diversity Action Plan Draft Guidance: From Strategic Planning Through Study Success

In recent decades, medical product development has increasingly embraced approaches that collect data mirroring real-world scenarios. US Food and Drug Administration (FDA)’s updated Draft Guidance “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” represents a significant step toward achieving greater generalizability of evidence for intended patient populations.
For successful implementation, an integrated and clear strategy is essential. It is crucial to engage partners who can effectively recruit, motivate and retain patients from underrepresented populations, but also analyze data within a new paradigm — one that embraces greater heterogeneity.
In this webinar, the expert speakers will delve into how clinical trial sponsors and contract research organizations (CROs) can approach compliance with FDA’s guidance on developing and implementing diversity action plans. Specifically, this webinar will explore the concept of an “Integrative Approach” that not only aligns with diversity action plans but also the promotion of equity in healthcare delivery and access.
The panelists will navigate the FDA diversity action plan guidance and seek to establish considerations for an integrative approach framework to enhance and improve patient-centric approaches to drug development — from trial design to patient outreach, recruitment, retention, variable data analysis and interpretation.
Register for this webinar today to explore how clinical trial sponsors and CROs can align with the FDA’s updated guidance on diversity action plans in clinical studies.
Keywords: FDA, Clinical Research, CRO, Patient Recruitment, Regulatory, FDA Guidance, Diversity, Patient Diversity, Clinical Trial Diversity, FDA Draft Guidance, Diversity Action Plans (DAPs)