Toward Clarification of Guideline to Classify Biomedical Engineering Researches under Clinical Trials Act of Japan

作     者：Kuroda, Tomohiro Sakurai, Risa Yoshimoto, Shunsuke Nakamura, Hideo Sugimachi, Masaru Kimura, Yuichi 

作者机构：Division of Medical IT and Administration Planning Kyoto University Hospital Japan Department of Research Promotion and Management National Cerebral and Cardiovascular Center Japan Department of Precision Engineering Graduate School of Engineering University of Tokyo Japan Department of Health Promotion and Sports Science Faculty of Biomedical Engineering Osaka Electro-Communication University Japan Department of Cardiovascular Dynamics National Cerebral and Cardiovascular Center Japan Department of Computational Systems Biology School of Biology-Oriented Science and Engineering Kindai University Japan 

出 版 物：《Transactions of Japanese Society for Medical and Biological Engineering》 (Trans. Jpn. Soc. Med. Biol. Eng.)

年 卷 期：2020年第Annual58卷第PROC期

页      面：550-552页

核心收录：

基　　金：This work was partly supported by a grant from the Science and technology project of Jilin provincial administration of traditional Chinese medicine: 2017160 and National Natural Science Foundation of China (NSFC): 81603324 

主　　题：Biomedical engineering 

摘      要：Japan has introduced Clinical Trials Act in April 2018 with unique definition of clinical trials. Once defined as a clinical trial, the research has to be conducted by ones with medical doctor license. As a result, the act discourages medical and biomedical engineering researchers, mostly engineering-origin researchers without medical doctor license, to engage in research activities. In order to promote medical and biomedical engineering researches, Japanese Society for Medical and Biomedical Engineering issued guideline for researchers to check whether a particular research is classified as clinical trial under the clinical trial act definition on October 2019. Although the guideline provides general classification criteria, contributions of members to develop detailed criteria should be given for each research approach, such as electric-stimuli, motor-assistance, etc. is expected. © 2020, Japan Soc. of Med. Electronics and Biol. Engineering. All rights reserved.