臨床評価における統計学上の論点：多重性の問題

• 渡邉 裕之

  万有製薬株式会社生物統計部

• 高橋 健一

  万有製薬株式会社生物統計部

書誌事項

タイトル別名

• Points to Consider on Multiplicity Issues in Clinical Trials
• リンショウ ヒョウカ ニ オケル トウケイガク ジョウ ノ ロンテン タジュウセイ ノ モンダイ

抄録

We would like to provide ideas about multiplicity from the practical point of view of a statistician in a pharmaceutical company. We think that a trial statistician should satisfy not only the requirements, described in ICH-E9, but should also be responsible for explaining statistical analyses, which may be complicated, to non-statisticians in simple language. In addition, certain multiple comparison methods that have been recently developed are hard to understand even for statisticians dealing with clinical trials. When these methods are applied to clinical trials, it is almost impossible to understand the essence of the multiple comparisons and interpret the results correctly. Therefore it is essential to plan a simple confirmatory clinical trial that can be interpreted clearly.

収録刊行物

• 計量生物学

  計量生物学 27 (Special_Issue), S73-S77, 2006

  日本計量生物学会

キーワード

• Multiplicity
• Clinical trial

詳細情報

• CRID: 1390282679345216128
• NII論文ID: 130002151747
• NII論文ID: 10018357532
• NII書誌ID: AA11591618
• DOI: 10.5691/jjb.27.s73
• ISSN: 21856494
• ISSN: 09184430
• NDL書誌ID: 8532485
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I8532485
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