Stratification Issues with Binary Endpoints
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Drug InJomrion l o u r n / , Vol. 35, pp. 1343-1350, 2001 Printed in the USA. All rights reserved.
STRATIFICATION ISSUES WITH BINARY ENDPOINTS* DEVANV. MEHROTRA, PHD Associate Director, Scientific Staff, Clinical Biostatistics, Merck Research Laboratories, Blue Bell, Pennsylvania
This note addresses four interrelated issues for a stratified comparative trial with a binary endpoint: 1. How to define the true overall treatment effect parameter; 2. How the strata should be weighted when conducting inference and estimation involving the overall treament effect, 3. How to (and how not to) test for a treatment by stratum (T x S ) interaction, and 4. When, why, and how the outcome of the T x S test should influence the weights assigned to each stratum. Numerical examples‘ are provided to reinforce the key points. Key Words: Binomial; Independent proportions; Interaction; Scale; Weighting
INTRODUCTION CONSIDER A DOUBLE BLIND randomized clinical trial designed to compare two treatments, designated control and test. Suppose it is known a priori that younger patients, say
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