東大病院におけるアカデミア主導の臨床開発の取組みと課題

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  • 荒川 義弘
    東京大学医学部附属病院臨床研究支援センター 東京大学医学部附属病院早期・探索開発推進室

書誌事項

タイトル別名
  • Recent Progress and Challenges in Investigator-driven Clinical Development of Novel Drugs and Medical Devices at The University of Tokyo Hospital
  • ヒガシダイビョウイン ニ オケル アカデミア シュドウ ノ リンショウ カイハツ ノ トリクミ ト カダイ

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  At the University of Tokyo Hospital, investigator-driven clinical development of novel drugs and medical devices is mainly supported by the Translational Research Center and Clinical Research Support Center. The former supports non-clinical research and the preparation of test materials and the latter supports clinical trials. The Clinical Research Support Center was established in 2010 by the reorganization of the former Clinical Research Center, which was established in 2001. The center adopted International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) as a standard guideline for clinical trials and prepared standard operation procedures and templates for protocols and informed consent documents in 2001 and, thereafter, provided consultation services to researchers for protocol development. In 2010, the service was extended to project management, data management and monitoring to support the credibility of clinical trials. In 2011, The University of Tokyo Hospital was selected by the government as a base for the early and exploratory clinical development of drugs in the fields of psychological and neurological diseases. For this purpose, a phase 1 unit for early phase clinical pharmacology trials is now being built. The center provides training courses for clinical research coordinators and hold seminars for clinical researchers; however, the biggest challenge remains the education and training of medical students who will lead clinical trials in the future.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 133 (2), 201-208, 2013-02-01

    公益社団法人 日本薬学会

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