Impact of the Clinical Trials Act 2018 on clinical trial activity in Japan from 2018 to 2020: a retrospective database study using new and conventional Japanese registries

• Published in: BMJ Open Vol. 12; no. 7; p. e059092
• Main Authors: Taruno, Hiroyuki, Oba, Mari S, Takizawa, Osamu, Kikuchi, Kayoko, Matsui, Kazuaki, Shikano, Mayumi
• Format: Journal Article
• Language: English
• Published: London British Medical Journal Publishing Group 01.07.2022; BMJ; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: Cancer; Classification; clinical governance; Clinical trials; Clinical Trials as Topic; Data Management; Databases, Factual; Drugs; Ethics; Food; Funding; Health Policy; Hospitals; Human subjects; Humans; Intervention; Japan; Life sciences; Marketing; Medical device industry; Medical equipment; Medicine; Observational studies; Pharmaceutical industry; R; Regenerative medicine; Registries; Regulation; Retrospective Studies; Statistical analysis; Trends; Japan

ObjectiveTo clarify the impact of Japan’s Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data.DesignRetrospective database study.SettingWe extracted information on clinical intervention studies registered bet...