Bayesian Approach to Utilize Historical Control Data in Clinical Trials

DOI Web Site Web Site 2 Citations 41 References Open Access
  • 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

Search this article

Description

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

Citations (2)*help

See more

References(41)*help

See more

Related Projects

See more

Keywords

Details 詳細情報について

Report a problem

Back to top