Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan.
BMC Med Res Methodol. 2013 Oct 25;13:130. doi: 10.1186/1471-2288-13-130.
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.
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.
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.
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.
国际临床试验目前正在迅速向亚洲扩展。然而，尽管两国都实施了类似的政府支持，韩国的全球试验比例却高于日本。临床试验环境的差异可能会影响各自医生对临床试验的态度和经验。因此，我们设计了一份问卷，以探讨两国医生如何看待临床试验相关问题。
2008 年，我们在京都大学医院（KUHP）和首尔国立大学医院（SNUH）进行了一项问卷调查。问卷包括 15 个问题和 2 个关于临床试验相关广泛关键问题的开放式问题。
KUHP 的应答人数为 301 人，SNUH 的应答人数为 398 人。有试验经验的医生在 KUHP 为 196 人，在 SNUH 为 150 人。其中，KUHP 有 12%（24/196）的人有全球试验经验，SNUH 有 41%（61/150）的人有全球试验经验。两所医院的大多数受访者都对临床试验持积极态度，并认为开展临床试验有助于医学进步，最终会带来新的更好的治疗方法。开展临床试验的主要障碍是缺乏人员支持和时间。两所大学医院的医生都认为，需要更多的临床研究协调员来更有效地开展临床试验。KUHP 的医生主要是出于纯粹的学术兴趣或寻找新疗法的愿望，而获得委员会认证学分和手稿共同署名也是 SNUH 医生的激励因素。
我们的结果表明，可能有两种不同的方法来增加临床试验活动。一种是建立提供足够的临床研究专业人员的临床试验基础设施的社会层面方法。另一种是为鼓励医生参与和开展临床试验提供激励措施的个人层面方法。
