The conditional binomial test revisited for clinical trials

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Abstract
McNemar's test is used to test the hypothesis that one treatment is better than another in a matched-pair design for binary outcomes. The conditional binomial test in such a matched-pair design is the exact McNemar test. However, in many clinical trials one wants to establish equivalency between two treatments. We discuss how to use a conditional binomial test to establish equivalency between two treatments in a matched-pair design. Sample size and power determination for each conditional binomial test are calculated. Some statistical properties of the tests are analyzed through Monte Carlo simulation.