Study on Compassionate Use Program-Survey of Expanded Access Clinical Trials Conducted between 2016 and 2022 in Japan

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  • UCHIDA Marika
    明治薬科大学レギュラトリーサイエンス研究室
  • ISHIBASHI Kota
    明治薬科大学レギュラトリーサイエンス研究室
  • MAEDA Hideki
    明治薬科大学レギュラトリーサイエンス研究室

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Other Title
  • 人道的見地から実施される治験（拡大治験）の検討―2016年から2022年に実施された拡大治験に関する調査―
  • ジンドウテキ ケンチ カラ ジッシ サレル チケン(カクダイチケン)ノ ケントウ : 2016ネン カラ 2022ネン ニ ジッシ サレタ カクダイチケン ニ カンスル チョウサ

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<p>Compassionate use is a system that allows a patient with a fatal disease access to an unapproved investigational drug in the clinical study phase as an exception in cases where no alternative therapy exists for the disease. In Japan, this system is referred to as an “expanded access clinical trial”. The system was established in January 2016 and has only been implemented for 6 years since then. A detailed investigation regarding actual status has thus yet to be conducted. On the basis of available data, the present study investigated the statuses of implementation for expanded access clinical trials conducted between January 2016 and the end of May 2022 in Japan. Collection of data from the 6 years revealed that a total of 36 expanded access clinical trials (for 31 drugs) had been conducted, making up 1.53% of pivotal clinical trials. Anticancer drugs were the most common drugs studied (24 of 36 trials). The present study shows that expanded access clinical trials were successfully implemented in fields of high social and patient demands during the 6 years, but do not appear to have been aggressively implemented.</p>

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