Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review

J Biopharm Stat. 2018;28(1):28-51. doi: 10.1080/10543406.2017.1378668. Epub 2017 Oct 30.


We review the design, data monitoring, and analyses of clinical trials with co-primary endpoints. Recently developed methods for fixed-sample and group-sequential settings are described. Practical considerations are discussed, and guidance for the application of these methods is provided.

Keywords: Co-primary endpoints (CPE); fixed-sample designs; group-sequential designs; intersection–union test (IUT); multiple primary endpoints (MPE); type II error adjustment.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data*
  • Data Interpretation, Statistical*
  • Endpoint Determination / methods*
  • Guidelines as Topic
  • Humans
  • Models, Statistical*
  • Research Design / statistics & numerical data*
  • Sample Size