Yanagawa Hiroaki, Irahara Minoru, Houchi Hitoshi, Kakehi Yoshiyuki, Moritoyo Takashi, Nomoto Masahiro, Miyamura Mitsuhiko, Shuin Taro
Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
J Med Invest. 2011 Feb;58(1-2):81-5. doi: 10.2152/jmi.58.81.
Clinical trials leading to drug approval (registration trials) play a central role in the drug development process. Since the introduction of the Good Clinical Practice (GCP) standard in 1997, the Japanese infrastructure for registration trials has improved. The contribution of support staff, including clinical research coordinators (CRCs), to clinical trials is now widely recognized in Japan. Quality issues and career development for these support staff are being increasingly emphasized. The Shikoku Collaborative Group for Promotion of Clinical Trials was organized in 2008 to address these issues through communication with the personnel involved in clinical trials in regional areas of Japan. To understand the views and present status of personnel involved in clinical trials, we used questionnaires to survey the participants of the First Symposium of the Shikoku Collaborative Group for Promotion of Clinical Trials held in August 2009. Group discussions and special lectures occurred at the symposium. The questionnaire began with questions about basic patient characteristics, followed by practical questions. Of 110 participants, there were 68 respondents (62%), including clinical trial support staff (clinical research coordinators [n=36, 53%], administrative officers [n=9, 13%]), and medical staff [n=23, 34%]). Among the support staff, 36 (80%) had more than 5 years of experience. The most common questionnaire answer selected for participation in the symposium was "willing to contact staff from other medical institutions or organizations" for support staff and "to obtain further knowledge concerning clinical trials" for medical staff. The overall view of the discussion ("Was the discussion satisfactory?") was favorable for 36 (53%) respondents. This survey revealed that the group discussion in the present symposium appears to be valuable for participants, using overall satisfaction as a surrogate. Based on the information obtained in the present study, further development of the clinical trial infrastructure, including training opportunities and career development for support staff, is required. Due to the limitations of this study, further analysis is warranted to determine the optimal strategy for training support staff.
促成药物获批的临床试验（注册试验）在药物研发过程中发挥着核心作用。自1997年引入《药物临床试验质量管理规范》（GCP）标准以来，日本的注册试验基础设施有所改善。包括临床研究协调员（CRC）在内的辅助人员对临床试验的贡献如今在日本已得到广泛认可。这些辅助人员的质量问题和职业发展正受到越来越多的重视。四国临床试验促进协作组于2008年成立，旨在通过与日本各地区参与临床试验的人员进行沟通来解决这些问题。为了解参与临床试验人员的观点和现状，我们通过问卷调查了2009年8月举行的四国临床试验促进协作组第一次研讨会的参会人员。研讨会上进行了小组讨论和专题讲座。问卷首先是关于患者基本特征的问题，接着是实际问题。在110名参会人员中，有68人回复（62%），包括临床试验辅助人员（临床研究协调员[n = 36，53%]、行政人员[n = 9，13%]）以及医务人员[n = 23，34%]）。在辅助人员中，36人（80%）有超过5年的工作经验。辅助人员参与研讨会最常选择的问卷答案是“愿意与其他医疗机构或组织的人员联系”，医务人员的答案是“获取更多关于临床试验的知识”。对于讨论的总体评价（“讨论是否令人满意？”），36名（53%）回复者给出了肯定的评价。这项调查显示，以总体满意度作为衡量标准，本次研讨会中的小组讨论对参会人员似乎是有价值的。基于本研究获得的信息，需要进一步发展临床试验基础设施，包括为辅助人员提供培训机会和职业发展规划。由于本研究存在局限性，有必要进行进一步分析以确定辅助人员培训的最佳策略。
