title: Testing homogeneity of two zero-inflated Poisson populations.
abstract: The problem of testing treatment difference in the occurrence of a safety parameter in a randomized parallel-group comparative clinical trial under the assumption that the number of occurrence follows a zero-inflated Poisson (ZIP) distribution is considered. Likelihood ratio tests (LRT) for homogeneity of two ZIP populations are derived under the hypotheses that (i) there is no difference in inflation parameters, (ii) there is no difference in non-zero means; and (iii) there is no difference in both inflation parameters and non-zero means. Approximate formulas for sample size calculation are also obtained for achieving a desired power for detecting a clinically meaningful difference under the corresponding alternative hypotheses. An example concerning the assessment of the gastrointestinal (GI) safety in terms of the number of erosion counts of a newly developed compound for the treatment of osteoarthritis and rheumatoid arthritis is given for illustration purpose.
authors.affiliation: Department of Management Sciences, City University of Hong Kong, Kowloon, Hong Kong. mssktse@cityu.edu.hk
authors.forename: Siu Keung
authors.initials: SK
authors.lastname: Tse
authors.forename: Shein Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Qingshu
authors.initials: Q
authors.lastname: Lu
authors.forename: Dennis
authors.initials: D
authors.lastname: Cosmatos
mesh_terms: D000465:Algorithms; D001699:Biometry / Q000379:methods; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination / Q000379:methods*; D004812:Epidemiologic Methods; D015233:Models, Statistical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D016012:Poisson Distribution; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors