Research for developing new continuous education curriculum for clinical researchers and specialists.

• Project/Area Number: 15K15164
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Medical sociology
• Research Institution: The University of Tokyo
• Principal Investigator: Svensson Kishi Akiko 東京大学, 医学部附属病院, 特任助教 (40750633)
• Co-Investigator(Kenkyū-buntansha): 河原崎 秀一 東京大学, 医学部附属病院, 登録診療員 (90722265) ; 高田 宗典 東京大学, 医学部附属病院, 助教 (70746841) ; 上村 夕香理 東京大学, 医学部附属病院, 助教 (80548537) ; 上田 哲也 東京大学, 医学部附属病院, 助教 (40272562)
• Project Period (FY): 2015-04-01 – 2017-03-31
• Project Status: Completed (Fiscal Year 2016)
• Budget Amount: ¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000); Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2015: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
• Keywords: 臨床研究 / 臨床試験 / 治験 / 研究者育成 / 教育 / トランスレーショナルリサーチ / 研修 / 倫理

Outline of Final Research Achievements

The Ethical Guidelines for Medical and Health Research Involving Human Subjects (2015) emphasized education and training for clinical researchers and specialists in the field. Due to the increased stringency and complexity of regulations, clinical researchers are required to increase not only knowledge of ethics, but also know-how of conducting research such as methodological, regulatory, and organizational expertise.
To ensure the quality and reliability of the clinical research, there is an urgent need for developing a continuous and systematic education. Therefore, this research sets as its overall goal to develop a systematic educational curriculum for global standard researchers by defining the necessary knowledge and ability required. We have until now met the following goals: 1) Defined the needs for education in the clinical research, 2) Conducted investigations of domestic/international education, and 3) Developed a comprehensive curriculum based on the acquired information.

Research Products

• [Journal Article] Japanese Initiative for Education in Pharmaceutical Medicine and Clinical Research Training. (2017)
  • Author(s): Akiko Kishi, Ichiro Uchida, Daisuke Koide, Kyoko Imamura
  • Journal Title: Journal of Medicine Development Sciences Volume: なし
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] 徹底分析シリーズ 薬が承認されるまで ｢人を対象とする医学系研究に関する倫理指針｣と臨床現場での対応-臨床研究の質と透明性確保のための歩み (2016)
  • Author(s): 岸 暁子
  • Journal Title: LiSA Volume: 23 Issue: 6 Pages: 532-536
  • DOI: 10.11477/mf.3101200584
  • ISSN: 1340-8836, 1883-5511
  • Year and Date: 2016-06-01
• [Journal Article] 東大病院における臨床研究者育成生涯教育研修の現状とそのカリキュラム構築 －「系統的臨床研究者・専門家の生涯教育」カリキュラム－ (2015)
  • Author(s): 岸暁子、上村夕香理
  • Journal Title: 化学療法の領域 Volume: Vol.31
• [Presentation] スタンフォード大学の創薬・診断法開発教育プログラム "SPARK"の東京大学における導入の取り組み (2017)
  • Author(s): 福島正哉 、岸暁子、木村紘子、前田佑二郎 、吉本真、加藤益弘 、木村廣道
  • Organizer: 日本臨床試験学会
  • Place of Presentation: 大阪
• [Presentation] Global collaboration and Education, Current Summary of curriculum development for clinical researchers and expansion of international collaboration (2015)
  • Author(s): Akiko Kishi Svensson
  • Organizer: The 2015 REACTA FORUM, REGIONAL ASIAN CLNICAL TRIAL ANNUAL FORUM
  • Place of Presentation: Chiba, Japan
  • Year and Date: 2015-11-26
  • Int'l Joint Research / Invited
• [Presentation] 東京大学における臨床研究者・専門スタッフ養成プログラム構築の活動報告 (2015)
  • Author(s): 岸 暁子
  • Organizer: ARO協議会第3回学術集会
  • Place of Presentation: 東京
  • Year and Date: 2015-09-17
• [Presentation] 東大での臨床試験研究者教育の取り組み (2015)
  • Author(s): 岸 暁子
  • Organizer: 第6回 日本製薬医学会 年次総会
  • Place of Presentation: 東京
  • Year and Date: 2015-07-24
  • Invited
• [Book] アカデミア創薬の実践ガイド (2017)
  • Author(s): ダリア モックリー＝ローゼン 編, ケビン グリムス 編, 加藤 益弘 総監訳, 木村 廣道 総監訳, 木村 紘子岸 暁子 監訳.
  • Total Pages: 260
  • Publisher: 東大出版
• [Remarks] 「系統的臨床研究者・専門家の生涯学習・研修」カリキュラム
  • URL: https://www.uhcta.com/uth/member/index.cfm