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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)
JonDavid Sparks, PhD
Principal Research Scientist, Eli Lilly and Company , United States
Design and Statistical Considerations of a Proposed Master Protocol
Stephen Lake, DRSc
Vice President, Biometrics, Wave Life Sciences, United States
Exploring Innovative Aspects of a Bayesian Adaptive Trial in Duchenne Muscular Dystrophy
Laura Lee Johnson, PhD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
An Overview of Innovative Designs and Statistical Considerations:Lessons Learned
John Scott, PhD, MA
Division Director, Office of Biostatistics, CBER, FDA, United States
General Considerations of Complex Innovative Trial Designs
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