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

• 小山 暢之

  三共株式会社臨床解析部

書誌事項

タイトル別名

• Discussion about Points to Consider on Switching between Superiority and Non-inferiority & Guideline on the Choice of Non-inferiority Margin
• Points to Consider on Switching between Superiority and Non inferiority Guideline on the Choice of Non inferiority Margin エ ノ トウロン

抄録

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 (Special_Issue), S105-S115, 2006

  日本計量生物学会

キーワード

• non-inferior trials
• non-inferior margin
• switching
• EMEA guideline

詳細情報

• CRID: 1390001204368487424
• NII論文ID: 10018357566
• NII書誌ID: AA11591618
• DOI: 10.5691/jjb.27.s105
• ISSN: 21856494
• ISSN: 09184430
• NDL書誌ID: 8532547
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I8532547
• データソース種別:
  • JaLC
  • NDL
  • Crossref
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可