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Abstract Details

Activity Number: 161
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305300
Title: Testing for Efficacy in Adaptive Clinical Trials with Enrichment
Author(s): Ying He*+ and Samuel S. Wu and Yi-Hsuan Tu
Companies: University of Florida and University of Florida and National Cheng Kung University
Address: P. O. Box 117450 , Gainesville, FL, 32610-745,
Keywords: Adaptive clinical trial ; Multiple testing ; Enrichment ; Strong control of experiment-wise type I error
Abstract:

Adaptive design of clinical trials has attracted considerable interest because of its potential to reduce costs and save time of the clinical development process. In this paper, we discuss enrichment designs that use accumulating data from a clinical trial to adaptively determine patient subgroup(s) in which the treatment effect is eventually assessed as well as adaptive sample size reestimation. We present a hypothesis testing procedure and a lower confidence limit for the treatment effect in the selected patient subgroup. The adaptive design is compared with the traditional group sequential method through a simulation study. In addition, the methods are illustrated with an application in the pain reduction trial.


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