本邦の医薬品開発におけるビッグデータ・リアルワールドデータの利活用に関する実態調査　―日本製薬工業協会加盟各社に対するアンケート調査―

DOI Web Site 参考文献5件
  • 前田 章太郎
    日本製薬工業協会医薬品評価委員会臨床評価部会 杏林製薬株式会社
  • 東郷 香苗
    日本製薬工業協会医薬品評価委員会臨床評価部会 ファイザー株式会社
  • 石黒 武蔵
    日本製薬工業協会医薬品評価委員会臨床評価部会 中外製薬株式会社
  • 井上 貴之
    日本製薬工業協会医薬品評価委員会臨床評価部会 日本製薬株式会社
  • 坂本 武彦
    日本製薬工業協会医薬品評価委員会臨床評価部会 ヤンセンファーマ株式会社
  • 菅野 公寿
    日本製薬工業協会医薬品評価委員会臨床評価部会 アストラゼネカ株式会社
  • 近藤 充弘
    日本製薬工業協会医薬品評価委員会臨床評価部会 大塚製薬株式会社

書誌事項

タイトル別名
  • A Questionnaire Survey of Pharmaceutical Companies Affiliated with Japan Pharmaceutical Manufacturers Association on Current Use of Big Data/Real-World Data for Drug Development in Japan

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説明

<p>Background: The use of big data/real-world data (BD/RWD) is expected to be a new option for evidence generation in drug development. Pharmaceutical companies are considered to be a group of key drivers to promote widespread use of BD/RWD in Japan. However, little is reported about the current status of the use of BD/RWD for drug development in Japan.</p><p>Objective: This study was conducted to reveal the current usage of BD/RWD by pharmaceutical companies in Japan and their current organization structure, with the aim to gain insight on the challenges and future perspective of BD/RWD in Japan.</p><p>Methods: A questionnaire survey was conducted on 66 pharmaceutical companies affiliated with Japan Pharmaceutical Manufacturers Association from 16 to 31 October 2018. The survey consisted of two parts: Questionnaire 1 investigated the current usage of BD/RWD in drug development in Japan, and Questionnaire 2 investigated the current organization structure.</p><p>Results: Of 52 companies that responded to Questionnaire 1, 30 companies (57.7％) were currently using BD/RWD for drug development in Japan for various purposes, 29 of which (96.7％) planned to continue using BD/RWD. Of 28 companies that responded to Questionnaire 2 and currently using BD/RWD, 9 companies (32.1％) had established divisions or organizations for internal management of BD/RWD, and 14 companies (50.0％) had standard operation procedures or guidance for handling legal and regulatory aspects associated with the use of BD/RWD for drug development in Japan.</p><p>Conclusion: BD/RWD is currently used for various purposes in drug development in Japan. However, the proportion of companies currently using BD/RWD for drug development is limited to approximately 50％. Proactive involvement of pharmaceutical companies toward the use of BD/RWD for drug development in Japan together with further industry-government-academia harmonization for environment improvement are awaited.</p>

収録刊行物

  • 臨床薬理

    臨床薬理 50 (4), 167-175, 2019-07-31

    一般社団法人 日本臨床薬理学会

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