JSM 2011 Online Program

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Abstract Details

Activity Number: 668
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301664
Title: Comparing Performance of Group Sequential Designs Using Haybittle-Peto-Type Boundaries with Sample Size Re-Estimation Designs
Author(s): Fang Fang*+ and Guangrui Zhu and Weichung Joe Shih and Yong Lin
Companies: Bayer HealthCare Pharmaceuticals Inc. and Eisai Medical Research, Inc. and University of Medicine and Dentistry of New Jersey and University of Medicine and Dentistry of New Jersey
Address: , , ,
Keywords: group sequential design ; Haybittle-Pete type boundary ; sample size re-estimation design
Abstract:

The sample size estimation in phase 3 clinical trials may not be able to accurately reflect the true treatment effect when limited efficacy data is available from early phase or historical studies. This lack of knowledge could jeopardize the clinical trial performance. Adaptive designs can optimize the trial performance and provide the flexibility of sample size adjustment during the trial by allowing early trial stopping or sample size re-estimation at the interim look. Comparisons of performance of group sequential designs using Haybittle-Peto type boundaries and sample size re-estimation designs on a treatment effect interval are done when assume treatment effect follows a uniform distribution or a beta distribution. As sample size re-estimation design is still belong to a less understood area, a properly selected group sequential design can be used to achieve the same or better performance as sample size re-estimation designs could.


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