代替エンドポイントの評価のための統計的基準とその適用事例  [in Japanese] Statistical Criteria for Surrogate Endpoint and Applications : A Review  [in Japanese]

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Author(s)

    • 田中 司朗 TANAKA Shiro
    • 京都大学医学部附属病院探索医療センター検証部 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital
    • 大庭 幸治 OBA Koji
    • 北海道大学病院 高度先進医療支援センター Translational Research and Clinical Trial Center, Hokkaido University Hospital
    • 吉村 健一 [他] YOSHIMURA Kenichi
    • 京都大学医学部附属病院探索医療センター検証部 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital
    • 手良向 聡 TERAMUKAI Satoshi
    • 京都大学医学部附属病院探索医療センター検証部 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital

Abstract

Surrogate endpoints, which represent a compromise in the conflict between measurability and clinical relevance of endpoints, have considerable advantage in rapid drug approvals compared to true endpoints in confirmatory clinical trials dealing with life-threatening diseases, such as cancer or AIDS. However, past experiences have shown the risk of relying too heavily on surrogate endpoints. In this paper, we review statistical criteria for evaluating surrogate endpoints and the past examples properly evaluated the surrogacy, taking into consideration relevant clinical and statistical issues.

Journal

  • Japanese Journal of Biometrics

    Japanese Journal of Biometrics 31(1), 23-48, 2010-07-31

    The Biometric Society of Japan

References:  71

Cited by:  1

Codes

  • NII Article ID (NAID)
    130000818347
  • NII NACSIS-CAT ID (NCID)
    AA11591618
  • Text Lang
    JPN
  • Article Type
    Journal Article
  • ISSN
    09184430
  • NDL Article ID
    10803286
  • NDL Source Classification
    ZR1(科学技術--生物学)
  • NDL Call No.
    Z74-B725
  • Data Source
    CJP  CJPref  NDL  J-STAGE 
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