臨床試験におけるヒストリカルコントロールデータの利用  [in Japanese] Bayesian Approach to Utilize Historical Control Data in Clinical Trials  [in Japanese]

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Author(s)

    • 武田 健太朗 Takeda Kentaro
    • 横浜市立大学大学院医学研究科臨床統計学・疫学 |アステラス製薬株式会社開発本部データサイエンス部 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine|Biostatistics Group, Data Science, Global Development, Astellas Pharma Inc.
    • 大庭 真梨 Oba Mari
    • 横浜市立大学大学院医学研究科臨床統計学・疫学 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine
    • 柿爪 智行 [他] Kakizume Tomoyuki
    • ノバルティスファーマ株式会社オンコロジー開発統括部オンコロジー生物統計・DM部 Oncology Biostatistics Group, Oncology Biometrics and Data Management Department, Novartis Pharma K.K.
    • 坂巻 顕太郎 Sakamaki Kentaro
    • 横浜市立大学大学院医学研究科臨床統計学・疫学 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine
    • 田栗 正隆 Taguri Masataka
    • 横浜市立大学大学院医学研究科臨床統計学・疫学 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine
    • 森田 智視 Morita Satoshi
    • 横浜市立大学大学院医学研究科臨床統計学・疫学 |京都大学大学院医学研究科医学統計生物情報学 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine|Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine

Abstract

It is expected to develop new drug more efficiently by incorporating historical data into the current study data. Borrowing historical data which is sufficiently similar to the current data allows increasing power and improving the accuracy of the estimated treatment effect. On the other hand, if the historical data is not similar to the current data, there is a potential for bias and inflated type I error rate. Power prior and hierarchical model are widely known as the Bayesian approaches with borrowing strength from historical information. They have the advantage of deciding the amount of historical information continuously depending on the similarity between historical data and current data. Our goal is to introduce power prior and hierarchical model while showing some examples, and provide a review of points to keep in mind when these approaches are used in the clinical trials.

Journal

  • Japanese Journal of Biometrics

    Japanese Journal of Biometrics 36(1), 25-50, 2015

    The Biometric Society of Japan

Codes

  • NII Article ID (NAID)
    130005097960
  • NII NACSIS-CAT ID (NCID)
    AA11591618
  • Text Lang
    JPN
  • ISSN
    0918-4430
  • NDL Article ID
    026649453
  • NDL Call No.
    Z74-B725
  • Data Source
    NDL  J-STAGE 
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