医院临床研究协调员的管理及运行模式探讨

Discussion on the management and operation mode of clinical research coordinators

在一项临床试验中,研究者需要同时从事临床医疗和临床试验,很难保证有足够的时间和精力完成高质量的临床试验。因此,为保证研究者对临床试验的依从性及提高临床研究质量,中国中医科学院西苑医院国家药物临床试验机构结合新药临床试验发展的新需求,与一家站点管理组织(Site ManagementOrganization,SMO)公司共同组建及管理临床研究协调员团队,制定人员选拔、培训及考核制度,针对我院标准操作规程及临床试验流程确定临床研究协调员团队各角色的工作职责及相应的工作流程,以解决临床试验质量提高与研究者精力相对不足之间的矛盾,保证研究者将主要精力集中在医学判断及受试者保护上,从而提高各方对临床试验方案的依从性。西苑医院建立的临床研究协调员运作模式是对公立医院临床研究模式进行的有益的实践探索,同时也是符合中国国情的新模式。

In a clinical trial,the investigators need to balance the routine clinical practice and the clinical trial,so it is difficult for them to spend adequate time and energy to conduct high quality clinical trial.In order to enhance the investigators＇ compliance and improve the quality of the clinical trials,the national clinical trial department of Xiyuan hospital,China Academy of Chinese Medical Sciences,in cooperation with the Site Management Organization（SMO） company,set up a clinical research coordinator team,established the personnel selection,training and assessment system,and defined the responsibilities and corresponding workflows of all parties according to internal SOPs and the clinical trial process.Xiyuan hospital＇s clinical research coordinator team,would solve the problem that the investigators did not have enough energy for the clinical trial,and ensure that they mainly focus on medical judgment and subjects protection,thus improve the compliance of all the parties to the protocol.The clinical research coordinator operation mode of Xiyuan hospital is a beneficial exploration for public hospitals in China,and it＇s also a new mode established according to Chinese national conditions.