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Activity Number: 22 - Design and Evaluation of Adaptive Design Clinical Trials: Software Demonstration
Type: Invited
Date/Time: Monday, August 3, 2020 : 10:00 AM to 11:50 AM
Sponsor: Section for Statistical Programmers and Analysts
Abstract #309487
Title: Design and Evaluation of Adaptive Design Clinical Trials: Software Demonstration
Author(s): Scott Berry* and Keaven Anderson* and Yannis Jemiai* and Dan Gillen*
Companies: Berry Consultants and Merck & Co and Cytel Inc and University of California, Irvine
Keywords: Adaptive Design Clinical Trials; Complex Innovative Designs; Simulation; R & Shiny; Multi-Arm Multi-Stage; Bayesian & frequentist operating characteristics
Abstract:

Adaptive designs for clinical trials play an increasingly important role in drug development after the signing of the PDUFA VI in 2017 and the FDA initiated pilot program on the use of Complex Innovative Designs. Software demonstrations by a panel of 4 trialists are planned: 1) Scott Berry (Berry Consultants) will demonstrate Fixed and Adaptive Clinical Trial Simulator (FACTS) to flexibly create custom trials and explore the efficiency of the different designs through simulation, including Bayesian and classical inference. 2) Keaven Anderson (Merck) will demonstrate gsDesign’s new capabilities for regulatory purposes using R and Shiny, focusing on designing group sequential (GS) trials under non-proportional hazards assumptions. 3) Yannis Jemiai (Cytel) will demonstrate East’s ability to design multi-arm multi-stage (MAMS) studies with options for early stopping, dose selection and sample size re-estimation that optimize power while strongly controlling the familywise error rate. 4) Dan Gillen (UC Irvine) will demonstrate RCTdesign’s ability to quickly evaluate and flexibly monitor a range of candidate GS designs, emphasizing both frequentist and Bayesian operating characteristics.


Authors who are presenting talks have a * after their name.

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