The FDAs Race and Ethnic Diversity Plan Guidance: How prepared is your organization?

Virtual

December 6, 2022

Virtual |

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In April 2022, the FDA released draft guidance for Race and Ethnicity Diversity Plans to ensure adequate enrollment of participants from underrepresented racial and ethnic populations in clinical trials. The guidance recommends that diversity plans should be submitted to the FDA for review early in clinical development, based on a framework provided in the guidance.
Operationalizing this guidance will require earlier planning and a shift from trial-level considerations to portfolio and disease-level planning and partnership strategies. This webinar brings together an expert panel from pharma, sites, and CROs to discuss the need for early engagement with sponsors and research partners, site-level strategies to reach underrepresented populations, and offers best practices for inclusive clinical trial designs.

The webinar will cover:

  • The impact of the diversity guidance on how clinical research is conducted
  • What fundamental change needs to happen?
  • How and when to create a diversity plan, including learnings from recent FDA feedback
  • The expanding role of community partnerships
  • Best practices for sites to identify and engage underrepresented populations

Hear from Parexel

Moderator:
Xoli Belgrave, MsC, PMP, Senior Director – Patient Innovation Center, Head of Clinical Trial Diversity, Equity & Inclusion, Parexel

Panel:
Clare Grace, Chief Patient Officer, Parexel
Kimberly Doggett, Head of Clinical Trial Diversity and Program Delivery Leads, UCB
Carlos Orantes, CEO, Alcanza Clinical Research LLC
Sophia McLeod, Director, Government Relations, Association of Clinical Research Organizations (ACRO)

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