Statistical Points to Consider on Switching between Non-inferiority and Superiority and on the Choice of Delta

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  • 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
  • ヒレッセイ ト ユウエツセイ ト ノ コウカン ト ヒレッセイ マージン ノ センタク ニ カンスル トウケイテキ ロンテン ニ ツイテ

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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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