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Sample size calculations for comparative clinical trials with over-dispersed Poisson process data.

Shigeyuki Matsui
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Abstract

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, inter-patient heterogeneity in event rate, and also, time-varying treatment effects. An application of the formula to a trial for chronic granulomatous disease is provided.

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Clinical Trials as TopicComputer SimulationGranulomatous Disease, ChronicHumansImmunotherapyInterferon-gammaPoisson DistributionSample SizeJournal Article

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Shigeyuki Matsui. 2005-05-15. Sample size calculations for comparative clinical trials with over-dispersed Poisson process data.. https://doi.org/10.1002/sim.2011

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