計量生物学
Online ISSN : 2185-6494
Print ISSN : 0918-4430
話題4:Points to Consider on Switching between Superiority and Non-inferiority; Guideline on the Choice of Non-inferiority Margin
非劣性と優越性との交換と非劣性マージンの選択に関する統計的論点について
丹後 俊郎
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2006 年 27 巻 Special_Issue 号 p. S116-S119

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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.

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© 2006 日本計量生物学会
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