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Session 3: Diversity, Equity and Inclusion in Innovative Clinical Trial Designs
Session Chair(s)
Terri Roberson, MBA
Associate Vice President, Clinical Design and Development
Eli Lilly and Company, United States
Freda Cooner, PhD
Senior Director - Statistics
Eli Lilly and Company, United States
Population disparity in clinical trials is recognized yet still a long-existing issue that contributes to the lack of data in minority groups. Other than routine subgroup analyses in FDA reviews, there has been little effort in enhancing patient population diversity in clinical trials. Recognizing this issue, FDA has recently published guidance documents on enhancing diversity through enrollment and trial designs. This session will have speakers discussing the FDA guidance, new technologies and trial designs that implement population diversity considerations, along with case studies and lessons learned.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define the recent FDA guidance documents on clinical trial population diversity
- Discuss new technologies and innovative trial designs that could potentially enhance trial population diversity
- Obtain information from case examples to avoid potential pitfalls
Speaker(s)
Generating Evidence for a Diverse Population
Lola Fashoyin-Aje, MD, MPH
FDA, United States
Office Director, Office of Clinical Evaluation, OTP, CBER
Technologies and Innovative Trial Designs to Enhance Population Diversity
Demissie Alemayehu, PhD
Pfizer Inc, United States
Vice President, Biostatistics
Speaker
Amy Hoover, BSN
Eli Lilly & Company, United States
Senior Director Clinical Development
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