Inference on the rate ratio of recurrent events for the matched pairs design

Authors

  • Mariko Sumi,

    Corresponding author
    1. Data Management Clinical Development Division, Actelion Pharmaceuticals Japan Ltd., 1-1-39 Hiroo Shibuya-ku, Tokyo 150-0012, Japan
    • Data Management Clinical Development Division, Actelion Pharmaceuticals Japan Ltd., 1-1-39 Hiroo Shibuya-ku, Tokyo 150-0012, Japan
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  • Toshiro Tango

    1. Department of Technology Assessment and Biostatistics, National Institute of Public Health, 3-6 Minami 2 chome, Wako, Saitama 351-0197, Japan
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Abstract

As statistical methods for testing the null hypothesis of no difference between two groups for the matched pairs design, the paired-t test, Wilcoxon signed rank sum test and McNemar test are well known. However, there is no simple test for the comparison of incidence rate of recurrent events. This paper proposes a simple statistical method and a sample size formula for the comparison of counts of recurrent events over a specified period of observation under the matched pairs design, where the subject-specific incidence of recurrent events is assumed to follow a time-homogeneous Poisson process. As a special case, the proposed method is found to be virtually equivalent in form to Mantel–Haenszel method for a common rate ratio among the set of stratified tables based on person-time data. The proposed methods are illustrated with the within-arm comparison of data from a clinical trial of 59 epileptics with baseline count data. Copyright © 2010 John Wiley & Sons, Ltd.

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