TWO-STAGE TESTING TO ESTABLISH NON-INFERIORITY IN THE STRATIFIED 2×2 CONTINGENCY TABLES

In this article we propose a two-stage testing procedure for demonstrating noninferiority of a test drug in stratified 2×2 contingency tables, which includes a preliminary test of homogeneity of odds ratios. In order to prove that a new drug is not inferior to a control by more than a prescribed amount, we use model-based methods such as the weighted least-square (WLS) procedure by Grizzle et al. (1969), and test the null hypothesis of a specified non-unity ratio. Also included are some results of a Monte Carlo study conducted to investigate the accuracy of the proposed test to the null distribution, and power of the test under small and moderate sample size configurations.