Sample size determination for jointly testing a cause-specific hazard and the all-cause hazard in the presence of competing risks.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Yang, Q; Fung, WK; Li, G

Published Date

  • April 2018

Published In

Volume / Issue

  • 37 / 8

Start / End Page

  • 1389 - 1401

PubMed ID

  • 29282764

Pubmed Central ID

  • 29282764

Electronic International Standard Serial Number (EISSN)

  • 1097-0258

International Standard Serial Number (ISSN)

  • 0277-6715

Digital Object Identifier (DOI)

  • 10.1002/sim.7590

Language

  • eng