重庆市药物临床试验机构现状分析及地区性机构体系构建的思考

Analysis of the current status of clinical drug trial institutions in Chongqing and reflections on the establishment of regional institutions

目的:重庆市具有丰富的医药产业底蕴和极佳的医疗资源,在我国药品注册审评制度改革紧密推进和重庆市大力发展生物医药产业的大背景下,本课题从对重庆市药物临床试验机构(以下简称机构)管理人员调研的角度入手,旨在明确重庆市机构建设现状与问题,探讨可行的创新发展对策。方法:本研究对我市20家有药物临床试验资质机构的54位管理人员问卷数据进行统计;并通过比对相应的公共数据,系统分析我市机构建设水平。结果:问卷分析显示,我市机构仍以传统GCP架构模式为主;以承担国内企业项目为主(90.00%),65.00%的机构近三年承接项目总数在40项以下;机构管理者多数从事机构相关工作的工作年限多在6年以内(79.59%),且仍有部分机构管理者未接受系统的培训;对公共数据调查分析显示,截至2019年5月底,我市机构总数目为22家,自2017年7月22日以来承接在Clinical Trails注册的在研项目数为81项,远低于机构工作开展较好的城市(北京:61家,433项;上海:53家,326项)。结论:重庆市机构建设水平亟待提高,应整合全市临床研究资源,构建区域化的药物临床试验机构体系,加速重庆市医药产业的创新发展。

AIM:Given the fact that Chongqing is a place rich in medical resource and the government is marking every effort in promoting the reform of drug clinical trial evaluation and the development of medical and health industry,the present study was designed to evaluating the current status of drug clinical research institute in Chongqing by investigating its administrative staff to further find ways for innovative development.METHODS:This study conducted a questionnaire survey on 54 managers from 20 clinical drug trial institutions in our city and systematically analyzed the level of institutions construction in our city by comparing the corresponding public data.RESULTS:Analyze of questionnaire survey revealed that the projected preformed in Chongqing were mainly from domestic pharmaceutical companies(90.00%)while 65%of the institutes took less than 40 projects in the past 3 years.The working seniority of administrative staff were mainly less than 6 years(79.59%)while some of the administrative staff still didn’t get systemic training on clinical research.Additionally,public data analyze has revealed that 81 projects were registered as"ongoing"on Clinical Trails.gov in the past 3 years in 22 drug clinical research institutes in Chongqing,which is much less than that in Beijing(61 institutes,433 projects)and Shanghai(53 institutes,326 projects).CONCLUSION:It is of great urgency to promote the development of drug clinical research institutes in Chongqing.The acceleration of innovative development of medical and health industry could be achieved by integrating the city’s medical resources and constructing regional drug clinical research institute system.