Abstract #301199

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JSM 2003 Abstract #301199
Activity Number: 30
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #301199
Title: Advantages and Disadvantages of Traditional Group Sequential Design and Two Adaptive Design Methodologies
Author(s): Xiaosha Zhang*+ and Min Chen and Joshua Cantor
Companies: Aventis and Aventis Pharmaceuticals, Inc. and Aventis Pharmaceuticals, Inc.
Address: 16 Hemlock Circle, Warren, NJ, 07059-2620,
Keywords: adaptive design ; O'Brien-Fleming ; simulation, futility ; CHW adaptive test
Abstract:

The application for adaptive design methodology in clinical trials has had increased acceptance among industry and regulatory agencies in recent years. In this research, a practical suggestion was provided for the design selection during the clinical trial protocol development stage when the treatment effect is underestimated, correctly estimated or overestimated. Several simulated examples were used to compare the traditional group sequential design using the O'Brien-Fleming stopping boundary with two adaptive design methods, CHW adaptive test based on different weight of each observation and a more general adaptive method based on equal weight of each observation together with futility stopping. A real life design example was provided to further facilitate the discussion.

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