A Survey of Physicians' Understanding of the Regulatory Systems for Clinical Trials in Japan
10.14442/general.14.92
- Author:
Yukie Yamauchi
;
Yumie Kawashima
;
Hisashi Urushihara
;
Fumiyo Uosaki
;
Yasutoshi Kobayashi
;
Shiro Hinotsu
;
Masao Nakagawa
;
Koji Kawakami
- Publication Type:Journal Article
- Keywords:
physicians;
questionnaire survey;
regulatory guidelines;
Japanese Good Clinical Practice;
investigational new drug;
non-commercial clinical trial
- From:General Medicine
2013;14(2):92-103
- CountryJapan
- Language:English
-
Abstract:
Background: Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.
This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials.
Methods: From 24th March to 24th April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8th July 2009.
Results: Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials.
Conclusion: Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.
