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Wednesday, June 22 • 11:15am - 12:15pm
#330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-619-L04-P ; CME 1.00; RN 1.00

If randomized clinical trials (RCTs) are enlarged to address treatment benefits and risks in subgroups of interest, they will take longer to complete. This forum considers regulatory, clinical and pharma use of real-world evidence to supplement RCT to address diversity. This forum will be a lively panel discussion with perspectives from the regulatory, clinical, and biopharmaceutical perspective, focusing on best ways to fill these evidence gaps including use of real-world evidence.

Learning Objectives

Summarize the trade-offs between running larger more diverse clinical trials and time to trial completion and product approval; Explain how the lack of diversity in clinical trials impacts the reliability of evidence-based care algorithms; Describe one or more ways that real-world evidence can contribute to understanding diversity and how that would extend what is learned from trials.


Nancy A. Dreyer, PhD, MPH, FISPE


Cathy W Critchlow, PhD, MSc

Wayne Batchelor, MD, MHS, FACC

John Concato, MD, MPH, MS


Wayne Batchelor

Director of Interventional Heart Program, Research and Innovation, Inova, United States
Dr. Wayne Batchelor currently serves as the Director or Interventional Cardiology, Director of Interventional Cardiology Research, Innovation and Education and Associate Director of the Inova Heart and Vascular Institute in Fairfax, VA and Adjunct Professor of Medicine at Duke Un... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & SVP, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA Real World Solutions and Adjunct Professor of Epidemiology at Univ of N Carolina at Chapel Hill. She leads the IQVIA Center for Advanced Evidence Generation and is a fellow of both the International Society for Pharmacoepidemiology... Read More →

Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  14: DIAmond, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum