Journal
STATISTICS IN BIOPHARMACEUTICAL RESEARCH
Volume 9, Issue 1, Pages 107-115Publisher
AMER STATISTICAL ASSOC
DOI: 10.1080/19466315.2016.1225594
Keywords
Count data; Equivalence test; Negative binomial model; Noninferiority test; Poisson model; Sample size calculation
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Poisson and negative binomial models are frequently used to analyze count data in clinical trials. While several sample size calculation methods have recently been developed for superiority tests for these two models, similar methods for noninferiority and equivalence tests are not available. When a noninferiority or equivalence trial is designed to compare Poisson or negative binomial rates, an appropriate method is needed to estimate the sample size to ensure the trial is properly powered. In this article, several sample size calculationmethods for noninferiority and equivalence tests have been derived based on Poisson and negative binomial models. All of these methods accounted for potential over-dispersion that commonly exists in count data obtained fromclinical trials. The precision of these methods was evaluated using simulations. Supplementary materials for this article are available online.
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