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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
Executive Director, 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)
Marc L Berger
Part-Time Consultant, Marc L. Berger, LLC , United States
ISPOR/ISPE Point of View on What Constitute “HETE Trial (Hypothesis Evaluation Treatment Effect” vs “Hypothesis Generation Trial” Using RWD
James Harnett, PharmD, MS
Executive Director, Health Economics and Outcomes Research, Regeneron Pharmaceuticals, Inc. , United States
Industry Perspective on the Potential for Randomized Pragmatic Clinical Trials
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
FDA Real World Evidence Framework
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