Author:
Ito-Ihara Toshiko,Hong Jeong-Hwa,Kim Ock-Joo,Sumi Eriko,Kim Soo-Youn,Tanaka Shiro,Narita Keiichi,Hatta Taichi,Choi Eun-Kyung,Choi Kyu-Jin,Miyagawa Takuya,Minami Manabu,Murayama Toshinori,Yokode Masayuki
Abstract
Abstract
Background
International clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians’ attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries.
Methods
A questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials.
Results
The number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH.
Conclusions
Our results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.
Publisher
Springer Science and Business Media LLC
Subject
Health Informatics,Epidemiology
Reference34 articles.
1. Thiers FA, Sinskey AJ, Berndt ER: Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008, 7: 13-14. 10.1038/nrd2441.
2. International Conference on Harmonisation (ICH): Guideline for good clinical practice E6(R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf,
3. Ministry of Health, Labour and Welfare: Ordinance on GCP. http://law.e-gov.go.jp/htmldata/H09/H09F03601000028.html,
4. Fukuhara S, Tanabe N, Sato K, Ohashi Y, Kurokawa K: Good clinical practice in Japan before and after ICH: problems and potential impacts on clinical trials and medical practice. Int J Pharm Med. 1997, 11: 147-153.
5. Hashimoto J, Ueda E, Narukawa M: The current situation of oncology drug Lag in Japan and strategic approaches for pharmaceutical companies. Drug Inf J. 2009, 43: 757-765. 10.1177/009286150904300613.
Cited by
13 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献