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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)
FDA Viewpoint
Lisa LaVange, PhD
University of North Carolina at Chapel Hill, United States
Professor Emerita
Innovative Dose-Finding Using Novel Adaptive Design and Analysis Approaches
Silke Jörgens
ICON Plc, Germany
Senior Statistical Consultant
Adaptive Designs: An Exercise in Change Management
Vladimir Dragalin, PhD
Janssen R&D, at Johnson & Johnson, United States
Vice President, Scientific Fellow
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