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Activity Number: 484 - Clinical Trial Design- 5
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #328907 Presentation
Title: A Model-Based Approach for Simulating Adaptive Clinical Studies with Surrogate Endpoints Used for Interim Decision-Making
Author(s): Xiaotian Chen* and Alan Hartford and Mei Li and Jun Zhao
Companies: AbbVie and AbbVie Inc and AbbVie and AbbVie
Keywords: adaptive design; surrogate endpoint; dose selection; Bayesian method; correlation model

In clinical trials, when exploring multiple dose groups to establish efficacy and safety on one or more selected doses, adaptive designs with interim dose selection are often used for dropping less effective dose groups. When it takes a long time to observe primary outcomes, utilizing information on a surrogate endpoint available at an earlier interim may be more efficient for selecting which dose to continue. We propose a Bayesian model-based approach where historical data are used to incorporate a correlation model for investigating the design's operating characteristics. Simulation studies were conducted and the method can be readily applied for power and sample size calculations.

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

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