Abstract
BackgroundInternational 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.MethodsA 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.ResultsThe 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.ConclusionsOur 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.
Highlights
International clinical trials are rapidly expanding into Asia
In Kyoto University Hospital (KUHP), faculty members were more likely to complete the survey than non-faculty members and the converse was true at Seoul National University Hospital (SNUH)
The differences in views between the Japanese and South Korean doctors might be explained by the success of the South Korean government in creating the necessary infrastructure for conducting clinical trials such as the establishment of 15 Regional Clinical Trial Centers (RCTCs)
Summary
International clinical trials are rapidly expanding into Asia. the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. There has been an increase in the globalization of clinical trials by the pharmaceutical industry, especially for biological products [1] Reasons cited for this shift include the ability to reduce operational costs while recruiting a large number of patients in a timely manner, the establishment of contact research organizations focused on global clinical trials, the expansion of market size, increased research capacity in emerging countries, improvements in regulatory development, and the harmonization of guidelines for clinical practice and research [1]. Japan has been experiencing a “Drug/Device Lag” phenomenon, where there is a delay in the approval of new drugs and devices that are already approved in the US and in European countries [4,5] To improve this negative situation, the Ministry of Health, Labour and Welfare (MHLW) of Japan has revamped their clinical trial consultation system to establish an environment more conducive to clinical trials and to enhance the participation of Japan in global clinical trials since 2003. The proportion of global trials in Japan still remains relatively low compared with other Asian countries: 7.5% of the total in 2007, 15.6% in 2008, and 20.2% in 2009 [10]
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