Bayesian Approach to Utilize Historical Control Data in Clinical Trials

• Takeda Kentaro

  Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine Biostatistics Group, Data Science, Global Development, Astellas Pharma Inc.

• Oba Mari

  Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine

• Kakizume Tomoyuki

  Oncology Biostatistics Group, Oncology Biometrics and Data Management Department, Novartis Pharma K.K.

• Sakamaki Kentaro

  Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine

• Taguri Masataka

  Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine

• Morita Satoshi

  Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine

Bibliographic Information

Other Title

• 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
• リンショウ シケン ニ オケル ヒストリカルコントロールデータ ノ リヨウ

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

Keywords

• Historical control
• Clinical trial
• Bayesian approach
• Power prior
• Hierarchical model
• Dynamic borrowing

Details

• CRID: 1390001204369760384
• NII Article ID: 130005097960
• NII Book ID: AA11591618
• DOI: 10.5691/jjb.36.25
• ISSN: 21856494
• ISSN: 09184430
• NDL BIB ID: 026649453
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I026649453
• Web Site: https://www.jstage.jst.go.jp/article/jjb/36/1/36_25/_pdf
• Text Lang: ja
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed