期刊
STATISTICS IN MEDICINE
卷 24, 期 9, 页码 1339-1356出版社
WILEY-BLACKWELL
DOI: 10.1002/sim.2011
关键词
recurrent events; over-dispersed Poisson process; clinical trials; sample size calculation
This paper develops a new formula for sample size Calculations for comparative clinical trials with Poisson or over-dispersed Poisson process data. The criteria for sample size calculations is developed on the basis of asymptotic approximations for a two-sample non-parametric test to compare the empirical event rate function between treatment groups. This formula can accommodate time heterogeneity, interpatient heterogeneity in event rate, and also, time-varying treatment effects. An application of the formula to a trial for chronic granulomatous disease is provided. Copyright (c) 2004 John Wiley & Sons, Ltd.
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