- 著者
- 前田 章太郎 東郷 香苗 石黒 武蔵 井上 貴之 坂本 武彦 菅野 公寿 近藤 充弘
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.50, no.4, pp.167-175, 2019-07-31 (Released:2019-08-24)
- 参考文献数
- 33
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.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.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.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.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.
- 著者
- 林元 みづき 庭田 祐一郎 伊藤 哲史 植木 進 内田 雄吾 関 洋平 西川 智章 岸本 早江子 神山 和彦 高杉 和弘 近藤 充弘
- 出版者
- 科学技術社会論学会
- 雑誌
- 科学技術社会論研究 (ISSN:13475843)
- 巻号頁・発行日
- vol.18, pp.119-127, 2020-04-30 (Released:2021-04-30)
- 参考文献数
- 4
- 被引用文献数
- 1
Patient Centricityとは「患者中心」を意味する概念であり,患者・市民参画(Patient and Public Involvement:PPI),Patient Involvement,Patient Engagementといった言葉と同義語である.近年,製薬企業が患者の意見や要望を直接入手し,患者の実体験を医薬品開発に活かすことの重要性が認識されつつあり,製薬企業での医薬品開発におけるPatient Centricityに基づく活動(本活動)が開始されている.本活動により,患者には「より参加しやすい治験が計画される」,「自分の意見が活かされた医薬品が開発される可能性がある」といったことが期待される.また,製薬企業には医薬品開発に新たな視点と価値が加わり,「より価値の高い医薬品の開発につながること」が期待される.本稿では,日本の製薬企業で実施されている本活動の事例の一部を紹介する.今後,日本の各製薬企業が本活動を推進することに期待したい.