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

Toshimitsu Hamasaki; Scott R Evans; Koko Asakura

doi:10.1080/10543406.2017.1378668

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.

Authors

Toshimitsu Hamasaki^{1

2}, Scott R Evans³, Koko Asakura^{1

2}

Affiliations

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.

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

Abstract

Publication types

MeSH terms

Grants and funding