ABSTRACT
Siyan Xu, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D’Agostino
ABSTRACT Noninferiority (NI) clinical trials are getting a lot of attention of late due to their direct application in biosimilar studies. One of the key assumptions on the NI test is constancy assumption. However, if a covariate interacts with the treatment arms, then changes in distribution of this covariate will likely result in violation of constancy assumption. This chapter presents four new NI methods and compares them with two existing methods to evaluate the change of background constancy assumption on the performance of these six methods.
