What Has Happened Since the Implementation of the Clinical Trials Act? Epidemiologists Need to Know
Author:
Affiliation:
1. Osaka Medical and Pharmaceutical University
2. Shizuoka Graduate University of Public Health
3. National Cancer Center Hospital
Publisher
Japan Epidemiological Association
Subject
General Medicine,Epidemiology
Link
https://www.jstage.jst.go.jp/article/jea/32/1/32_JE20210425/_pdf
Reference8 articles.
1. 1. Tsutsumi I, Tsutsumi Y, Yoshida C, Komeno T, Imanaka Y. Impact of the Clinical Trials Act on noncommercial clinical research in Japan: an interrupted time-series analysis. J Epidemiol. 2022;32:27–33.
2. 2. Nakamura K, Shibata T. Regulatory changes after the enforcement of the new Clinical Trials Act in Japan. Jpn J Clin Oncol. 2020;50:399–404.
3. 3. Nakamura K. Response and challenges to the Clinical Trial Act in the research supporting field. Web symposeum of the Society for Regulatory Science of Medical Products. 2021 [in Japanese].
4. 4. Kunito E, Ariyoshi K, Inoue A, Tsuboi M. A Survey of Researchers on Clinical Trial Act. Jpn Pharmacol Ther. 2019:S59-S66 [in Japanese].
5. 5. Japan Clinical Oncology Group. Protocol Manual. [cited 2021 4 Oct]. Available from: http://www.jcog.jp/doctor/tool/manual.html [in Japanese].
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