臨床研究法が医療機器開発研究に与えた影響の実態把握に向けた調査研究報告

DOI

抄録

<p>The clinical trials act of Japan, enforced April 2018, which allows only medical doctor license holders to perform clinical trials using unauthenticated medical devices had a strong impact to medical device development researches which are mainly performed by engineering researchers. The authors conducted online survey for understanding impact of the act on medical device development researches in November 2021. The total number of responses was 46, 35% of them are forced to modify or abort their original research plan, although most of them has no need to do so. This survey result clarifies that education for review board members about medical device development researches and slight amendment of the act to enable medical device development researches are required for promotion of medical device development researches.</p>

収録刊行物

  • 生体医工学

    生体医工学 Annual60 (Abstract), 78_1-78_1, 2022

    公益社団法人 日本生体医工学会

詳細情報 詳細情報について

  • CRID
    1390857226429371264
  • DOI
    10.11239/jsmbe.annual60.78_1
  • ISSN
    18814379
    1347443X
  • 本文言語コード
    ja
  • データソース種別
    • JaLC
  • 抄録ライセンスフラグ
    使用不可

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