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Activity Number: 308 - Adaptive Design - 2
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329781 Presentation
Title: A Model-Based Conditional Power Assessment for Decision Making in Randomized Controlled Trial Studies
Author(s): Baiming Zou* and Jianwen Cai and Gary G. Koch and Haibo Zhou and Fei Zou
Companies: University of Florida and University of North Carolina and University of North Carolina and University of North Carolina and University of North Carolina at Chapel Hill
Keywords: conditional power; interim analysis; clinical trial; decision making; model-based analysis

Conditional power based on summary statistic by comparing outcomes (such as the sample mean) directly between two groups is a convenient tool for decision making in randomized controlled trial studies. In this paper, we extend the traditional summary statistic-based conditional power with a general model-based assessment strategy, where the test statistic is based on a regression model. Asymptotic relationships between parameter estimates based on the observed interim data and final unobserved data are established, from which we develop an analytic model-based conditional power assessment for both Gaussian and non-Gaussian data. The model-based strategy is not only flexible in handling baseline covariate and more powerful in detecting the treatment effects compared with the conventional method, but also more robust in controlling the overall type I error under certain missing data mechanisms. The performance of the proposed method is evaluated by extensive simulation studies and illustrated with an application to a clinical study.

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

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