著者

寒水 孝司 杉本 知之 濱崎 俊光

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.34, no.1, pp.35-52, 2013-08-31 (Released:2013-09-20)

参考文献数

61

被引用文献数

1

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Clinical trials often employ two or more primary endpoints because a single endpoint may not provide a comprehensive picture of the intervention’s effects. In such clinical trials, a decision is generally made as to whether it is desirable to evaluate the joint effects on all endpoints (i.e., co.primary endpoints) or at least one of the endpoints. This decision defines the alternative hypothesis to be tested and provides a framework for approaching trial design. In this article, we discuss recent statistical issues in clinical trials with multiple primary endpoints. Especially, we introduce the methods for power and sample size determinations in clinical trials with co-primary endpoints, considering the correlations among the endpoints into the calculations. We also discuss the methods to alleviate conservativeness of testing co-primary endpoints.