Points to Consider on Switching between Superiority and Non-inferiority & Guideline on the Choice of Non-inferiority Margin への討論 Discussion about Points to Consider on Switching between Superiority and Non-inferiority & Guideline on the Choice of Non-inferiority Margin

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Two guidelines related to non-inferiority trials were released by the European Medicines Agency (EMEA). One pertains to the choice of non-inferiority margin and the other to switching the objective of a trial between superiority and non-inferiority. These guidelines describe principles for appropriately designing and interpreting non-inferior trials, but it is very difficult to follow these principles in an actual clinical trial setting. In this article, recommendations in interpreting these guidelines are discussed from a sponsor statisticians' point of view. Some issues of non-inferior trials not mentioned in these guidelines are also discussed.

収録刊行物

  • 計量生物学  

    計量生物学 27, S105-S115, 2006-09-30 

    The Biometric Society of Japan

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各種コード

  • NII論文ID(NAID)
    10018357566
  • NII書誌ID(NCID)
    AA11591618
  • 本文言語コード
    JPN
  • 資料種別
    REV
  • ISSN
    0918-4430
  • NDL 記事登録ID
    8532547
  • NDL 雑誌分類
    ZR1(科学技術--生物学)
  • NDL 請求記号
    Z74-B725
  • データ提供元
    CJP書誌  NDL  J-STAGE 
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