Regarding Paper“Sample size determination in clinical trials with multiple co‐primary endpoints including mixed continuous and binary variables”by T. Sozu, T. Sugimoto, and T. HamasakiBiometrical Journal (2012) 54(5): 716–729Article: http://dx.doi.org/10.1002/bimj.201100221Authors' Reply: http://dx.doi.org/10.1002/bimj.201300032This paper recently introduced a methodology for calculating the sample size in clinical trials with multiple mixed binary and continuous co‐primary endpoints modeled by the so‐called conditional grouped continuous model (CGCM). The purpose of this note is to clarify certain aspects of the methodology and propose an alternative approach based on latent means tests for the binary endpoints. We demonstrate that our approach is more powerful, yielding smaller sample sizes at powers comparable to those used in the paper.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.