Points to Consider on Multiplicity Issues in Clinical Trials の内容紹介および問題提起 Review of "Points to Consider on Multiplicity Issues in Clinical Trials" and Issues to be Discussed

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"Points to Consider on Multiplicity Issues in Clinical Trials" published by CPMP of EMEA in September 2003 is reviewed and issues to be discussed are identified. First, the examples identified in the PtC as unnecessary cases of "adjusting the type I error level" are grouped into 3 patterns, and the situation and the characteristics of each pattern are explained. After reviewing each pattern, important points for conducting the confirmatory trial according to PtC are summarized. Issues to be discussed about the content and the concrete measures are also addressed.

収録刊行物

  • 計量生物学  

    計量生物学 27, S64-S72, 2006-09-30 

    The Biometric Society of Japan

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各種コード

  • NII論文ID(NAID)
    10018357526
  • 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
    8532481
  • 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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