Abstract
Self and Mauritsen developed a sample size determination procedure for score tests in generalized linear models under contiguous alternatives. Its performance may deteriorate when the effect size is large. We propose a modification of the Self–Mauritsen method by taking into account of the variance of the score statistic under both the null and alternative hypotheses, and extend the method to noninferiority trials. The modified approach is employed to calculate the sample size for the logistic regression and negative binomial regression in superiority and noninferiority trials. We further explain why the formulae recently derived by Zhu and Lakkis tend to underestimate the required sample size for the negative binomial regression. Numerical examples are used to demonstrate the accuracy of the proposed method.
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