TY - JOUR
T1 - Survey on centralization of research ethics review for multicenter clinical trials in Japan
AU - Inano, Akihiro
AU - Uchida, Eiji
AU - Inoue, Yusuke
AU - Kusuoka, Hideo
AU - Tashiro, Shimon
AU - Hasegawa, Junichi
AU - Morishita, Noriko
AU - Sasaguri, Toshiyuki
N1 - Funding Information:
Research Ethics Committee of the Japanese Society of Clinical Pharmacology and Therapeutics ＊1 Clinical Research Center, Fukushima Medical University Hospital, 1 Hikarigaoka, Fukushima 960-1295, Japan ＊2 Showa University, Japan ＊3 University of Tokyo, Japan ＊4 National Hospital Organization, Japan ＊5 National Cancer Center Japan, Japan ＊6 Tottori University, Japan ＊7 Osaka National Hospital, Japan ＊8 Kyusyu University, Japan
Publisher Copyright:
Copyright © 2018 the Japanese Society of Clinical Pharmacology and Therapeutics（JSCPT)
PY - 2018
Y1 - 2018
N2 - We conducted a survey on centralization of research ethics review for multicenter clinical trials under the Pharmaceuticals and Medical Devises Law and calculated thedeinstitutionalization (referred to review not conducted by local IRB)rate for each type of clinical trial. We confirmed a trend of increase in overall deinstitutionalization rate from FY2008 to FY2013. The rate was 64.5％ for phase III clinical trials in FY2013. However, the rate was extremely low in oncology trials, and was only 6.5％. Using our summarized data, we estimated that the resource spent on initial reviews for multicenter clinical trials amounted to 2 billion yen in 5 years. In the whole clinical trial arena, we need to consider carefully the balance between safeguarding research ethics and ensuring efficiency of the resource spent for this purpose.
AB - We conducted a survey on centralization of research ethics review for multicenter clinical trials under the Pharmaceuticals and Medical Devises Law and calculated thedeinstitutionalization (referred to review not conducted by local IRB)rate for each type of clinical trial. We confirmed a trend of increase in overall deinstitutionalization rate from FY2008 to FY2013. The rate was 64.5％ for phase III clinical trials in FY2013. However, the rate was extremely low in oncology trials, and was only 6.5％. Using our summarized data, we estimated that the resource spent on initial reviews for multicenter clinical trials amounted to 2 billion yen in 5 years. In the whole clinical trial arena, we need to consider carefully the balance between safeguarding research ethics and ensuring efficiency of the resource spent for this purpose.
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U2 - 10.3999/jscpt.49.159
DO - 10.3999/jscpt.49.159
M3 - Review article
AN - SCOPUS:85052578757
SN - 0388-1601
VL - 49
SP - 159
EP - 167
JO - Japanese Journal of Clinical Pharmacology and Therapeutics
JF - Japanese Journal of Clinical Pharmacology and Therapeutics
IS - 4
ER -