Format

Send to

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

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

Author information

1
a Department of Data Science , National Cerebral and Cardiovascular Center , Osaka , Japan.
2
b Department of Innovative Clinical Trials and Data Science , Osaka University Graduate School of Medicine , Osaka , Japan.
3
c Department of Biostatistics and the Center for Biostatistics in AIDS Research , Harvard T.H. Chan School of Public Heath , MA , USA.

Abstract

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

Supplemental Content

Full text links

Icon for PubMed Central
Loading ...
Support Center