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Separating Perceptions from Reality in the Acceptance of Adaptive Trials by Regulatory Agencies
Session Chair(s)
David Ohlssen, PHD
Senior Expert Methodologist, Novartis Pharmaceuticals Corporation, United States
Innovative Dose-Finding Using Novel Adaptive Design and Analysis Approaches
Learning Objective : Interpret the intent of the FDA guidance on adaptive designs; Identify key factors required by regulators in the review of adaptive trials; Apply adaptive trials within their own clinical development programs.
Speaker(s)
Lisa LaVange, PHD
Professor Emerita, University of North Carolina at Chapel Hill, United States
FDA Viewpoint
Silke Jörgens
Senior Statistical Consultant, ICON Plc, Germany
Innovative Dose-Finding Using Novel Adaptive Design and Analysis Approaches
Vladimir Dragalin, PHD
Vice President, Scientific Fellow, Janssen R&D, at Johnson & Johnson, United States
Adaptive Designs: An Exercise in Change Management
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