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Session 5: The Role of Pragmatic Trials for Regulatory Problems
Session Chair(s)
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
Frank W. Rockhold, PhD, MSc
Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States
Mark Levenson, PhD
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
FDA, United States
Regulators and industry are actively exploring the use of real world evidence (RWE) to address important regulatory problems. Randomized pragmatic trials provide a promising source of RWE. This session considers the role of pragmatic trials for regulatory problems and focuses on the clinical and statistical objectives of pragmatic trials and their appropriateness for regulatory problems.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe what is a pragmatic trial
- Explain various possible objectives of pragmatic trials
- Understand the various estimands to achieve the objectives
Speaker(s)
Per-Protocol Analyses of Pragmatic Trials
Miguel Hernan, DrPH, MD
Department of Epidemiology, Harvard T.H. Chan School of Public Health, United States
Professor
ITT Analyses of Pragmatic Trials: Is the 21st Century Different from the Past?
Janet Turk Wittes, PhD
Statistics Collaborative Inc., United States
President
Panelist
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
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