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The FDA Complex Innovative Trial Design Pilot Program: Case Examples
Session Chair(s)
Dionne Price, PHD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
A goal of the FDA Complex Innovative Trial Design Pilot Program is to facilitate the use of complex adaptive, Bayesian and other novel designs. This forum will present case examples from the Pilot Program and discuss FDA and industry interactions.
Learning Objective : Describe examples of innovative clinical trials in the regulatory setting; Discuss regulatory and industry statistical interactions as a part of the CID Pilot Program
Speaker(s)
Design and Statistical Considerations of a Proposed Master Protocol
JonDavid Sparks, PHD
Eli Lilly and Company , United States
Principal Research Scientist
Exploring Innovative Aspects of a Bayesian Adaptive Trial in Duchenne Muscular Dystrophy
Stephen Lake, DRSC
Wave Life Sciences, United States
Vice President, Biometrics
An Overview of Innovative Designs and Statistical Considerations:Lessons Learned
Laura Lee Johnson, PHD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
General Considerations of Complex Innovative Trial Designs
John Scott, PHD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER