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Evaluation ViewAttendees 23

Biopharmaceuticals (includes Biologics and Drugs)

Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial Diversity

Thursday, October 5, 2023
8:00 AM – 9:15 AM EDT
Location/Room: 513D
Achieving health equity in clinical trials is a high priority in our industry. Understanding how to develop, execute and measure clinical trials diversity objectives and goals and how to report to Regulatory Agencies is of paramount importance across different stakeholder groups. This session will discuss multistakeholder approaches, including the latest FDA efforts that may enhance participation of underrepresented populations in clinical trials. Additional discussion will cover opportunities that are cross-collaborative and community-based, with a focus on supporting local sites, clinical trial staff, and patients in underserved communities to enhance clinical trial diversity in a sustainable way. In addition, recent legislature allows for the FDA to enforce Diversity Plans and we will discuss current challenges and opportunities This session will also include discussion on how other Regulatory Agencies are implementing measures for Sponsors to track and report trial diversity metrics.

Learning Objectives:

  • Describe at least three components of the FDA Diversity Plan Draft Guidance.
  • Discuss community-based solutions to clinical trial access and participation by underrepresented populations.
  • Identify cross-collaborative efforts and resources aimed at enhancing diversity in clinical trials, including input from patients and the community.