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Clinical Trial Optimization Podcast

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Clinical Trials with WCG’s Lori Abrams and Senior Advisor Linda Sullivan


What’s the current status of diversity efforts in clinical trials given the recent FDA draft guidance and the introduction of the Diverse and Equitable Participation in Clinical Trials (DEPICT) in Congress? That’s the main topic explored during WCG Senior Advisor’s interview with Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, at WCG. Abrams has a long history of improving clinical drug development by including patients, caregivers, and advocacy groups into every aspect of the development continuum. In her last corporate role, Lori was Director of Diversity & Patient Engagement at Bristol-Myers Squibb (BMS) where she built one of the first clinical trial advocacy groups in R&D in pharma.

Sullivan and Abrams discuss the most important diversity and patient voice developments in clinical trials, including General Considerations for Clinical Studies/Guidance for Industry, adopted by ICH in October 2021; FDA’s guidance on Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry released in Nov 2020; FDA’s draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry released on April 13, 2022, and the DEPICT Act, which was introduced in the United States Congress on February 9, 2022. The legislation aims to boost diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials. Abrams also talks about how these changes have increased the urgency that sponsors now feel to implement patient diversity programs.

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