Trends in Investigator-Initiated Clinical Studies at a University Hospital after Enforcement of the 2018 Clinical Trials Act in Japan-Reference-Cited by-同舟云学术

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

Published:2022-03-01 Issue:3 Volume:45 Page:374-377
ISSN:0918-6158
Container-title:Biological and Pharmaceutical Bulletin
language:en
Short-container-title:Biological & Pharmaceutical Bulletin

Author:

Sato Yasutaka¹,Sakaguchi Satoshi¹,Takechi Kenshi¹,Chuma Masayuki¹,Yagi Kenta¹,Kane Chikako¹,Goda Mitsuhiro¹,Hamano Hirofumi¹,Aoe Yuki¹,Nokihara Hiroshi¹,Kubo Yoshiaki²,Hashimoto Ichiro³,Yanagawa Hiroaki¹

Affiliation:

1. Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital

2. Ethics Committee of Tokushima University Hospital, Tokushima University Hospital

3. Certified Review Board of Tokushima University, Tokushima University

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology,General Medicine

Link

https://www.jstage.jst.go.jp/article/bpb/45/3/45_b21-00753/_pdf

Reference15 articles.

1. 1) Yanagawa H. Current regulatory systems for clinical trials in Japan: still room for improvement. Clin. Res. Regul. Aff., 31, 25–28 (2014).

2. 2) Urushihara H, Kawakami K. Academic clinical trials and drug regulations in japan: impacts of introducing the investigational new drug system. Ther. Innov. Regul. Sci., 48, 463–472 (2014).

3. 3) Yanagawa H, Katashima R, Takeda N. Research ethics committees in Japan: a perspective from thirty years of experience at Tokushima University. J. Med. Invest., 62, 114–118 (2015).

4. 4) Normile D. Tampered data cast shadow on drug trial. Science, 341, 223 (2013).

5. 5) Ministry of Health. Labour and Welfare. “Ethical guidelines for medical and health research involving human subjects.”: ‹https://www.mhlw.go.jp/content/10600000/000757206.pdf›, accessed 29 November, 2021.

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