JSM 2004 - Toronto

Abstract #300949

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Activity Number: 235
Type: Luncheons
Date/Time: Tuesday, August 10, 2004 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300949
Title: Stratified Clinical Trials--Some Bread and Butter Issues
Author(s): Devan V. Mehrotra*+
Companies: Merck & Co., Inc.
Address: UN-A102, Blue Bell, PA, 19422,
Keywords: binary data ; interaction ; Mantel-Haenszel test ; minimum risk weights ; random stratum sizes
Abstract:

We will discuss fundamental statistical issues involving comparative clinical trials with stratification. First, we will differentiate between prognostic and nonprognostic factor stratification. Second, we will stress the importance of clearly stating the null hypothesis being tested. Third, we will review some recently developed alternatives to the popular Mantel-Haenszel procedure, and discuss the related issue of stratum-weighting. Fourth, we will describe how to (and how not to!) test for a treatment by stratum (TxS) interaction, and what to do in the presence of an interaction. Finally, we will comment on the issue of random stratum sizes and discuss the related impact on interval estimates of the "true overall treatment effect." Illustrative examples and simulation results will be used to reinforce the key points.

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Revised March 2004