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Session 3: Real World Data and Its Fit for Regulatory Purpose
Session Chair(s)
Frank W. Rockhold, PhD, MSc
Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States
William Wang, PhD
President
Merck & Co, Inc, United States
Mark Levenson, PhD
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
FDA, United States
The healthcare system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data. Leveraging such data to improve regulatory decisions is a key strategic priority for the FDA. On December 6, 2018, FDA announced its strategic framework on using real world evidence (RWE). In this session, we will discuss the three key considerations in the FDA framework: (1) Whether the RWD are fit for use; (2) Whether the trial or study design used to generate RWE can provide adequate scientific evidence to answer or help answer the regulatory question; and (3) Whether the study conduct meets FDA regulatory requirements (e.g., for study monitoring and data collection).
Speaker(s)
ISPOR/ISPE Point of View on What Constitute “HETE Trial (Hypothesis Evaluation Treatment Effect” vs “Hypothesis Generation Trial” Using RWD
Marc L Berger
Marc L. Berger, LLC , United States
Part-Time Consultant
Industry Perspective on the Potential for Randomized Pragmatic Clinical Trials
James Harnett, PharmD, MS
Regeneron Pharmaceuticals, Inc. , United States
Executive Director, Health Economics and Outcomes Research
FDA Real World Evidence Framework
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE