国立循環器病研究センターにおける早期・探索的臨床試験の取り組みと課題

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  • 山本 晴子
    独立行政法人国立循環器病研究センター研究開発基盤センター先進医療・治験推進部

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タイトル別名
  • The Path to the Execution of Explorative Clinical Researches in National Cerebral and Cardiovascular Center (NCVC)
  • コクリツ ジュンカンキビョウ ケンキュウ センター ニ オケル ソウキ ・ タンサクテキ リンショウ シケン ノ トリクミ ト カダイ

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  In the Ministry of Health, Labour and Welfare's (MHLW) “5-year plan for activating clinical trials”, we have put in place the infrastructure including human resources for supporting not only commercial clinical trials but also those initiated by academic researchers, including clinical research coordinator (CRC) support and consultation for planning clinical trial with biostatistician. We also prepared a data management unit and trained data managers for academic clinical trials. In 2011, the National Cerebral and Cardiovascular Center (NCVC) was selected one of the sites of the MHLW project of structure improvement to execute early phase clinical trials. To clinically develop medical devices invented by the NCVC researchers involved in the project, animal experiments which meet the GLP standards must be finished before the first-in-human clinical trial. We are planning to create the units containing human resources for developing medical devices such as professionals in regulatory affairs, safety tests, and Good Laboratory Practice (GLP) systems. Creation of a smooth pathway from the preclinical to the clinical phases will be key to the efficient development of new medical devices.<br>

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  • 薬学雑誌

    薬学雑誌 133 (2), 209-212, 2013-02-01

    公益社団法人 日本薬学会

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