JSM 2004 - Toronto

Abstract #300749

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Activity Number: 29
Type: Contributed
Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300749
Title: The Application of Enhanced Parallel Gatekeeping Strategies
Author(s): Xun Chen*+ and Edmund Luo and Thomas Capizzi
Companies: Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
Address: RY34-A316, Rahway, NJ, 07065,
Keywords: enhanced procedures ; gatekeeping strategy ; interrelationships ; matched tests
Abstract:

The parallel "gatekeeping strategy" proposed by Dmitrienko et al. (2003) provides a flexible framework for the pursuit of strong control on studywise Type I error rate. This paper further explores the application of the weighted Simes parallel gatekeeping procedure recommended by Dmitrienko et al. and proposes some modifications to better incorporate the interrelationships of different hypotheses in actual clinical trials and to achieve better power performance. We first propose a simple method to quantitatively control the impact of secondary tests on the testing of primary hypotheses when applying the weighted Simes parallel gatekeeping procedure. We then introduce an idea of matching the gatekeeping relationship between individual primary and secondary tests whenever applicable to more appropriately address the logical relationships between primary and secondary tests. Our simulation study demonstrates that when applicable, the enhanced gatekeeping procedures generally results in more powerful tests than the ordinary parallel gatekeeping procedure in Dmitrienko et al..


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