臨床評価における統計学上の論点：欠測値の諸問題

• 渡辺 秀章

  塩野義製薬（株）医薬研究開発本部解析センター

• 田崎 武信

  塩野義製薬（株）医薬研究開発本部解析センター

書誌事項

タイトル別名

• Points to Consider on Missing Data
• 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 ケッソクチ ノ ショ モンダイ

抄録

In clinical trials, missing data often happens for a variety of reasons, such as dropouts, making it difficult to analyze the primary variable measured longitudinally and to interpret the results of the primary analysis. While handling missing data sometimes causes bias in the results, there have been no established statistical approaches applied to missing data in appropriate situations. In November 2001, Committee for Proprietary Medical Product of the European Medicines Agency, issued “Points to Consider (PtC) on Missing Data”, which focuses on several points that should be taken into account when handling missing data in clinical trials. In this paper, we review the contents of this PtC, which assumes that the primary analysis is based on the ITT principle, and discuss some of the approaches for handling missing data and the difficulties in interpreting these results.

収録刊行物

• 計量生物学

  計量生物学 27 (Special_Issue), S33-S44, 2006

  日本計量生物学会

キーワード

• Clinical trial
• Longitudinal data
• Missing data
• Drop-out
• LOCF
• Imputation

詳細情報

• CRID: 1390282679345185152
• NII論文ID: 10018357473
• NII書誌ID: AA11591618
• DOI: 10.5691/jjb.27.s33
• ISSN: 21856494
• ISSN: 09184430
• NDL書誌ID: 8532424
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I8532424
• 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