日本小児循環器学会による治験促進活動

DOI
  • 三浦 大
    地方独立行政法人東京都立病院機構東京都立総合医療センター循環器科

書誌事項

タイトル別名
  • Clinical trial promotion project of the Japanese Society of Pediatric Cardiology and Cardiac Surgery

抄録

<p>Unapproved and off–label use of drugs and devices have several problems : insufficient evidence, unstable supplies, serious adverse effects not covered by the official relief system, disadvantage of physicians in the event of a lawsuit, assessment of reimbursements, etc. Moreover, clinical trials for pediatric and rare diseases are often not conducted owing to their poor profitability and the difficulty of developing drugs and devices and recruiting patients.</p><p>For these reasons, the Clinical Trial Committee of the Japanese Society of Pediatric Cardiology and Cardiac Surgery (hereinafter the Society) began a clinical trial promotion project in 2015 and renewed the initiative in 2018. The society receives compensation under contract with a sponsor, and the project team provides support at each stage of a clinical trial : 1) pre–trial (planning, survey of eligible patients and their willingness to participate, and selecting institutions for participation) ; 2) during the trial (holding meetings, publicity and provision of information to members of the Society) ; and 3) post–trial (preparing reports and articles, conducting post–marketing surveillance, etc.).</p><p>To date, the Society has facilitated the testing and approval of seven drugs and three surgical materials through this program. Clinical trials have been completed for five subjects, one of which has qualified for insurance coverage and is now available commercially. Experience has shown that clinical trials that progress quickly are characterized by the following : 1) pediatric trials are initiated before approval for insurance coverage is obtained for adult patients ; 2) strategy meetings are held frequently ; and 3) the Society is involved from the planning stage to improve feasibility.</p><p>We hope that the Society's system for supporting clinical trials under contract with sponsors will help promote clinical trials in collaboration with industry, government, and academia so that patients can receive effective and safe treatments that qualify for insurance coverage as soon as possible.</p>

収録刊行物

  • 神経治療学

    神経治療学 40 (3), 187-191, 2023

    日本神経治療学会

詳細情報 詳細情報について

  • CRID
    1390015719773505280
  • DOI
    10.15082/jsnt.40.3_187
  • ISSN
    21897824
    09168443
  • 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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