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Sample size calculations for comparative clinical trials with over‐dispersed Poisson process data
Author(s) -
Matsui Shigeyuki
Publication year - 2005
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.2011
Subject(s) - sample size determination , poisson distribution , statistics , event (particle physics) , parametric statistics , sample (material) , mathematics , clinical trial , computer science , econometrics , medicine , physics , quantum mechanics , thermodynamics
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. Copyright © 2004 John Wiley & Sons, Ltd.