Design,data monitoring,and analysis of clinical trials with co-primary endpoints: A review |
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| Authors: | Toshimitsu Hamasaki Scott R. Evans Koko Asakura |
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| Affiliation: | 1. Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan;2. Department of Innovative Clinical Trials and Data Science, Osaka University Graduate School of Medicine, Osaka, Japantoshi.hamasaki@ncvc.go.jp;4. Department of Biostatistics and the Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Heath, MA, USA;5. Department of Innovative Clinical Trials and Data Science, Osaka University Graduate School of Medicine, Osaka, Japan |
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| Abstract: | ABSTRACTWe 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. |
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| Keywords: | Co-primary endpoints (CPE) fixed-sample designs group-sequential designs intersection–union test (IUT) multiple primary endpoints (MPE) type II error adjustment |
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