Equivalence tests before end of follow-up under the class of log transformation model

Abstract

ABSTRACT One important topic in clinical trials is to show that the effects of new and standard treatments are equivalent in terms of clinical relevance. In literature, many equivalence tests based on the maximal difference between two survival functions for the two treatments over the whole time axis have been proposed. However, since survival times can only be observed until the end of follow-up, an equivalence test should be based on a comparison only in the observed time-window dictated by the end of follow-up. In this article, under the class of log transformation model, we propose an asymptotical -level equivalence test for the difference between two survival functions that only addresses equivalence until the end of follow-up. We demonstrate that the hypothesis of equivalence of two survival functions before the end of follow-up can be formulated as interval-based hypothesis testing which involves the treatment effect parameter. Simulation results indicate that when sample size is sufficiently large the proposed test controls the type I error effectively and performs well at detecting the equivalence. The proposed test is applied to a dataset from veteran’s administration lung cancer trial.