著者

丹後 俊郎

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.27, no.Special_Issue, pp.S116-S119, 2006-09-30 (Released:2012-01-23)

参考文献数

1

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This short note discusses statistical issues in the appropriate design of randomized controlled trials with regards to the recent two documents, “Points to Consider on Switching between Superiority and Non-inferiority” and “Guideline on the Choice of the Non-inferiority Margin” from the European Agency for the Evaluation of Medicinal Products. This paper also points out the inappropriateness of the terminology of “superiority”defined in ICH E9 (Statistical Principles for Clinical Trials) and discusses its relationship with these matters.