Comparison in Utilization of Disease Registry for Clinical Trials and New Drug Applications Among Japan and Americas

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  • 日米における疾患レジストリの臨床試験および新薬承認申請への利用比較
  • ニチベイ ニ オケル シッカン レジストリ ノ リンショウ シケン オヨビ シンヤク ショウニン シンセイ エ ノ リヨウ ヒカク

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Abstract

<p>The utilization of disease registry is expected to conduct clinical trials/researches effectively, accelerate drug development, and deliver drugs on market speedy. MHLW and AMED started clinical innovation network (CIN), which includes six projects to prepare the high-quality registry in Japan. The status of registry utilization was surveyed in Japan, US, and Canada and made comparison between in Japan and US. US has 53 registries excluding 5 survey registries and Japan has 154 registries. 28 registries were matched both US and Japan based on diseases. The quality of registry has still improvement points for using those in new drug application in Japan. That in US was unclear based on the information of website. The scale of registries was various. The case of including registry data in new drug submission was not quite sufficient among countries. No registry based randomized clinical trial (Registry Based RCT) in Japan was conducted. On the other hand, five Registry Based RCTs were conducted by the State, or the hospital network in US. In conclusion, the utilization of registry in both countries is under development. Pharmaceutical industry, academia, and the government should collaborate to implement registry data to deliver innovative drugs to patients as soon as possible.</p>

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