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Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials
Session Chair(s)
Rachele Hendricks-Sturrup, DrSc, MA, MSc
Research Director, Real-World Evidence
Duke-Robert J. Margolis, MD, Center for Health Policy, 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
Merck & Co., Inc., United States
Senior Director, Epidemiology
Panelist
Christina Mack, PhD, MPH
IQVIA, United States
Chief Scientific Officer, Real-World Solutions
Panelist
Catherine Lerro, PhD, MPH
FDA, United States
Senior Pharmacoepidemiologist, Oncology Center of Excellence
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