期刊
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
卷 21, 期 4, 页码 650-668出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2011.551329
关键词
Intersection-union test; Multivariate Bernoulli; Multivariate normal; Power; Two-arm design
资金
- Ministry of Education, Culture, Sports, Science and Technology, Japan [20500255, 22700290]
- Pfizer Health Research Foundation, Japan
In pharmaceutical drug development, for regulatory purposes, there are increasing discussions on the establishment of statistically significant results demonstrating the efficacy of a new treatment on multiple co-primary endpoints. At the design stage with multiple co-primary endpoints, it is critical to determine the appropriate sample size for indicating statistical significance for all co-primary endpoints with preserving the intended power set, since the type II error increases as the number of co-primary endpoints increases. We provide fundamental formulae for power and sample size calculation with multiple co-primary endpoints and illustrate the aspect of the provided methods through numerical tables and examples.
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