Exact power and sample size calculations for the two one-sided tests of equivalence

Abstract

Equivalent testing has been strongly recommended for demonstrating the comparability of treatment effects in a wide variety of research fields including medical studies. Although the essential properties of the favorable two one-sided tests of equivalence have been addressed in the literature, the associated power and sample size calculations were illustrated mainly for selecting the most appropriate approximate method. Moreover, conventional power analysis does not consider the allocation restrictions and cost issues of different sample size choices. To extend the practical usefulness of the two one-sided tests procedure, this article describes exact approaches to sample size determinations under various allocation and cost considerations. Because the presented features are not generally available in common software packages, both R and SAS computer codes are presented to implement the suggested power and sample size computations for planning equivalence studies. The exact power function of the TOST procedure is employed to compute optimal sample sizes under four design schemes allowing for different allocation and cost concerns. The proposed power and sample size methodology should be useful for medical sciences to plan equivalence studies.