An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital

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.

Figure 1

The merits of conducting clinical trials for doctors. (KUHP, n = 301; SNUH, n = 398). In Question #8 “What do you think are the merits of conducting clinical trials?”, the participants were asked to rate nine items by how strongly they agree using the following 4-tier scale: strongly agree, agree, partially agree, and disagree. The proportion of doctors responding as “strongly agree and agree” and “partially agree and disagree” in each institution was compared. 301 doctors at KUHP and 398 doctors at SNUH responded to the question.

Figure 2

Major problems faced by doctors with clinical trial experience (KUHP, n = 196; SNUH, n = 150). In Question #10 “What are the major problems in conducting clinical trials?”, the participants were asked to answer the question according to the level of seriousness: a serious problem, a problem, a small problem, and no problem. The proportion of doctors responding as “a serious problem and a problem” and “a small problem and no problem” in each institution was compared. 196 doctors at KUHP and 150 doctors at SNUH with clinical trial experience responded to this question.

Figure 3

Obstacles in multinational clinical trials. In Question #16, the participants with global clinical trial experience were asked to rate 7 potential obstacles faced in a multinational clinical trial by their level of seriousness according to a 4-tier scale: a serious problem, a problem, a small problem, and no problem. The proportion of doctors responding as “a serious problem and a problem” and “a small problem and no problem” in each institution were compared. 24 and 61 doctors with global clinical trial experience at KUHP and SNUH, respectively, were answered in the question.

Figure 4

Sources of information relating to clinical trials. When asked about the place where they acquired knowledge related to clinical trials in question #13, 569 answers from 297 doctors at KUHP and 433 answers from 380 doctors at SNUH were obtained. 4 doctors (a doctor with clinical trial experience and 3 of doctors without clinical trial experience) at KUHP and 18 doctors (6 doctors with clinical trial experience, 11 doctors without experience, and a doctor who did not state their trial experience) at SNUH did not respond to the question.

Figure 5

Necessary conditions for overcoming the obstacles in conducting clinical trials at university hospitals. In Question#14 “What do you think is important for overcoming the obstacles for the development of clinical trials?”, the participants were asked to rate 6 items by importance: very important, important, partially important, and not important. The proportion of doctors responding as “very important and important” and “partially important and not important” in each institution were compared. 196 doctors in KUHP and 150 doctors in SNUH with clinical trial experience responded to this question.

Figure 6

Specialized training programs necessary for development of personnel. In Question #15, among the 5 different types of personnel required for running clinical trials (investigators, clinical pharmacologists/pharmaceutical physicians, clinical research coordinators/research nurses, data managers/biostatisticians, qualified regulatory government officials), the doctors were asked who they thought the most effort into training should be placed. Answers from 196 doctors with and 104 doctors without clinical trial experience were obtained from KUHP. Answers from 150 doctors with and 242 doctors without clinical trial experience were obtained from SNUH.