研究者发起的临床研究项目质量控制体系探讨

Discussions on the quality control system of investigator initiated trials in the new circumstances

我国在逐步加强对医疗卫生机构开展的研究者发起的临床研究(investigator initiated trials,IIT)的规范管理,建立健全IIT项目质量控制体系越来越受到重视。作者通过检索国内外医疗机构和科研院所临床研究相关部门的官方网站,结合文献研究法,梳理国内外IIT项目质量管理现状,发现我国尚存在质量管理标准及规范缺乏、质控机制不健全、质量风险意识不强、质量监督力度不够以及临床研究人员质控能力不足等问题。建议我国在构建IIT项目质量控制体系时应制定适用于IIT项目的质量管理标准和规范、建立系统的质控机制(如探索建立由项目组/科室-医院-国家监督机构/同行评议专家团队等组成的三级质控模式、推行全流程质控机制)、加强政策引导和制度建设以及强化对临床研究人员的规范化培训等。

China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions,spotlighting the establishment and improvement of the quality control system of IIT projects than ever before.The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad,and by means of literature review analyzed the current quality management of IIT projects at home and abroad.They found such setbacks as lack of quality management standards and norms,imperfect quality control mechanism,poor awareness of quality risk,insufficient quality supervision and poor quality control ability of clinical researchers.Based on the above,the paper made the following recommendations for building an IIT project quality control system in China:developing quality management standards and norms,setting up a systematic quality control mechanism(i.e.,exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team,and implementing the whole process quality control mechanism),strengthening policy guidance and system construction,and strengthening the standardized training of clinical researchers.