Survey on centralization of research ethics review for multicenter clinical trials in Japan

Akihiro Inano; Eiji Uchida; Yusuke Inoue; Hideo Kusuoka; Shimon Tashiro; Junichi Hasegawa; Noriko Morishita; Toshiyuki Sasaguri

doi:10.3999/jscpt.49.159

Survey on centralization of research ethics review for multicenter clinical trials in Japan

Akihiro Inano, Eiji Uchida, Yusuke Inoue, Hideo Kusuoka, Shimon Tashiro, Junichi Hasegawa, Noriko Morishita, Toshiyuki Sasaguri

Research output: Contribution to journal › Review article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	159-167
Number of pages	9
Journal	Japanese Journal of Clinical Pharmacology and Therapeutics
Volume	49
Issue number	4
DOIs	https://doi.org/10.3999/jscpt.49.159
Publication status	Published - 2018
Externally published	Yes

Keywords

Clinical trial
IRB
Research ethics

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.3999/jscpt.49.159

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Survey on centralization of research ethics review for multicenter clinical trials in Japan. / Inano, Akihiro; Uchida, Eiji; Inoue, Yusuke; Kusuoka, Hideo; Tashiro, Shimon; Hasegawa, Junichi; Morishita, Noriko; Sasaguri, Toshiyuki.

In: Japanese Journal of Clinical Pharmacology and Therapeutics, Vol. 49, No. 4, 2018, p. 159-167.

Research output: Contribution to journal › Review article › peer-review

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abstract = "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.",

keywords = "Clinical trial, IRB, Research ethics",

author = "Akihiro Inano and Eiji Uchida and Yusuke Inoue and Hideo Kusuoka and Shimon Tashiro and Junichi Hasegawa and Noriko Morishita and Toshiyuki Sasaguri",

note = "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 {\textcopyright} 2018 the Japanese Society of Clinical Pharmacology and Therapeutics（JSCPT)",

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doi = "10.3999/jscpt.49.159",

language = "English",

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pages = "159--167",

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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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Survey on centralization of research ethics review for multicenter clinical trials in Japan

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