Trends in Investigator-Initiated Clinical Studies at a University Hospital after Enforcement of the 2018 Clinical Trials Act in Japan

• Published in: Biological & pharmaceutical bulletin Vol. 45; no. 3; pp. 374 - 377
• Main Authors: Goda, Mitsuhiro, Kane, Chikako, Kubo, Yoshiaki, Nokihara, Hiroshi, Hashimoto, Ichiro, Yagi, Kenta, Sato, Yasutaka, Sakaguchi, Satoshi, Hamano, Hirofumi, Chuma, Masayuki, Takechi, Kenshi, Yanagawa, Hiroaki, Aoe, Yuki
• Format: Journal Article
• Language: English
• Published: Japan The Pharmaceutical Society of Japan 01.03.2022; Japan Science and Technology Agency
• Subjects: clinical research; Clinical trials; Clinical Trials Act; Clinical Trials as Topic - legislation & jurisprudence; Enforcement; Hospitals, University; Humans; investigator; Japan; trend; Japan; investigator; Clinical Trials Act; clinical research; trend; Japan

In April 2018, the Clinical Trials Act pertaining to investigator-initiated clinical trials was passed in Japan. The purpose of this study was to investigate activity in investigator-initiated clinical studies before and after enforcement of the new Clinical Trials Act. This was done by analysing th...