The Views of Doctors on Registration Trials in a Japanese Rural Area: A Survey of Medical Institutions Registered to the Tokushima Network for Clinical Trials

Yanagawa, Hiroaki; Irahara, Minoru; Kawashima, Shu; Kagawa, Satomi

doi:10.1177/147323000803600532

Cited by 4 publications

(1 citation statement)

References 6 publications

(13 reference statements)

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“…This is now spreading as a means of promoting clinical trials. In 2004, in order to spread information of the supporting system of the CTCDT in the regional area, Tokushima University Hospital, in collaboration with the Tokushima Medical Association, set up the Tokushima Network for Clinical Trials (TNCT) which comprises regional medical institutions [ 11 ]. The TNCT's mission is to gain a clearer understanding of the methodology in support of clinical trials in various areas and situations and to promote clinical trials in this rural area of Japan.…”

Section: Discussionmentioning

confidence: 99%

Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

Yanagawa¹,

Akaishi²,

Miyamoto³

et al. 2008

Int Arch Med

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Background: Clinical trials play a central role in the establishment of clinical evidence, and the important role of clinical research coordinators (CRCs) in various processes of clinical trials is now widely recognized. In Japan, many CRCs work under the discretion of their hospital and support clinical trials in various areas. Modification of CRC activity pursuant to the types of clinical trials may make roles of the CRC more effective and meaningful. In the present study, we examine the dedicated role of the CRC considering the specialty of a registration trial of a drug for surgical patients used during the operation period.

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Section: Discussionmentioning

confidence: 99%

Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

Yanagawa¹,

Akaishi²,

Miyamoto³

et al. 2008

Int Arch Med

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Present status of Japanese ethics committees: a survey in Tokushima Prefecture

Katashima

Sato

Kinoshita³

et al. 2014

J. Med. Invest.

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: Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in collaboration with the Tokushima Medical Association. A questionnaire was established and mailed to all medical institutions (n=737) registered to the Tokushima Medical Association in 2012. Among 737, 223 (30.3% %) questionnaires were returned and 221 were completed and are included in this analysis (respondents). Among respondents, 51 (23.1% %) had performed clinical research, and of these, 17 had established ethics committees (though one was omitted from the following analysis due to an unsatisfactory response). Among 16 ethics committees, review of protocol amendments, review of serious adverse events, annual follow-up of approved protocols, and education for committee members were active in 10 (62.5% %), 9 (56.3% %), 6 (37.5% %) and 4 (25.0% %), respectively. Research ethics education was active in 4 (25.0% %). Based on the results, we attempt to establish an appropriate system for ethical conduct of health-related research in Tokushima Prefecture.

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Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University

2015

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: The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions.

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The Views of Doctors on Registration Trials in a Japanese Rural Area: A Survey of Medical Institutions Registered to the Tokushima Network for Clinical Trials

Cited by 4 publications

References 6 publications

Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

Present status of Japanese ethics committees: a survey in Tokushima Prefecture

Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University

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