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Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials
Session Chair(s)
Rachele Hendricks-Sturrup, MA
Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States
In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.
Learning Objective : Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.
Speaker(s)
Panelist
Mehmet Burcu, PhD, MS, FISPE
Senior Director, Epidemiology, Merck & Co., Inc., United States
Panelist
Christina Mack, MPH
CSO RWE and SVP AAIS, IQVIA, United States
Panelist
Catherine Lerro, PhD, MPH
Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
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