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Evaluation ViewAttendees 19

Biopharmaceuticals (includes Biologics and Drugs)

Lessons Learned Since the Implementation of FDA’s Diversity Plans & an Assessment of the 2024 Diversity Action Plans FDA Guidance

Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT
Location/Room: 203
Enhancing clinical trial diversity requires a multistakeholder approach including regulatory guidance and industry sponsored clinical trial initiatives. This session will discuss the lessons learned (challenges and opportunities) since the publication of FDA’s Diversity Plans to improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. It will also provide analysis* of the newly released FDA guidance on Diversity Action Plans and the implications to sponsor companies. Lastly it will provide an overview of an industry sponsored initiative to enhance diversity in clinical trials through a community-based initiative Equitable Breakthroughs in Medicine Development (EQBMED).

Learning Objectives:

  • Provide and overview of the FDA Diversity Action Plan Draft Guidance.
  • Identify cross-collaborative efforts and resources aimed at enhancing diversity in clinical trials.
  • Discuss opportunities to increase clinical trial access and participation by underrepresented populations.