This article considers sample size determination for jointly testing a cause‐specific hazard and the all‐cause hazard for competing risks data. The cause‐specific hazard and the all‐cause hazard jointly characterize important study end points such as the disease‐specific survival and overall survival, which are commonly used as coprimary end points in clinical trials. Specifically, we derive sample size calculation methods for 2‐group comparisons based on an asymptotic chi‐square joint test and a maximum joint test of the aforementioned quantities, taking into account censoring due to lost to follow‐up as well as staggered entry and administrative censoring. We illustrate the application of the proposed methods using the Die Deutsche Diabetes Dialyse Studies clinical trial. An R package “powerCompRisk” has been developed and made available at the CRAN R library.
Statistics in Medicine – Wiley
Published: Jan 15, 2018
Keywords: ; ; ; ;
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