Sample Size Determination for Establishing Equivalence/Noninferiority via Ratio of Two Proportions in Matched-Pair Design

In this article, we propose approximate sample size formulas for establishing equivalence or noninferiority of two treatments in match-pairs design. Using the ratio of two proportions as the equivalence measure, we derive sample size formulas based on a score statistic for two types of analyses: hypothesis testing and confidence interval estimation. Depending on the purpose of a study, these formulas can be used to provide a sample size estimate that guarantees a prespecified power of a hypothesis test at a certain significance level or controls the width of a confidence interval with a certain confidence level. Our empirical results confirm that these score methods are reliable in terms of true size, coverage probability, and skewness. A liver scan detection study is used to illustrate the proposed methods.