Inference on the rate ratio of recurrent events for the matched pairs design |
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Authors: | Sumi Mariko Tango Toshiro |
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Institution: | Data Management Clinical Development Division, Actelion Pharmaceuticals Japan Ltd., 1-1-39 Hiroo Shibuya-ku, Tokyo 150-0012, Japan. Mariko.Sumi@actelion.com |
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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. |
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