title: Sample size calculations for comparative clinical trials with over-dispersed Poisson process data.
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.
authors.affiliation: Department of Pharmacoepidemiology, School of Public Health, Kyoto University, Kyoto 606-8501, Japan. matsui@pbh.med.kyoto-u.ac.jp
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Matsui
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D006105:Granulomatous Disease, Chronic / Q000276:immunology; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D007371:Interferon-gamma / Q000276:immunology / Q000627:therapeutic use; D016012:Poisson Distribution; D018401:Sample Size
chemical_list: D007371:Interferon-gamma