探索建立深圳市临床研究技术支持和监管体系  

To establish clinical research technical support and supervision system in Shengzhen

作　　者：吉萍 张超[1] 肖平 刘敏 周丽萍 武阳丰[3] Ji Ping;Zhang Chao;Xiao Ping;Liu Min;Zhou Liping;Wu Yangfeng(Shenzhen-Peking University The Hongkong University of Science & Technology Medical Center,Shenzhen 518036,Guangdong Province,P.R.China)

机构地区：[1]深圳北京大学香港科技大学医学中心,518036 [2]深圳市卫生计生委 [3]北京大学临床研究所

出　　处：《中华医学科研管理杂志》2018年第6期404-406,411,共4页Chinese Journal of Medical Science Research Management

摘　　要：目的随着深圳政府及医疗机构出台鼓励性政策,对临床研究项目投入日益增多,迫切需要探索建设一个良好有效的临床研究技术支持和监管体系。方法通过调研及访谈了解深圳临床研究现状及需求;围绕需求,加强顶层设计,制定工作规划;有序按规划推进体系的建设。结果初步总结深圳市临床研究体系建设的工作成效:政府启动了临床研究体系和技术平台建设;从无到有建立了多层级深圳市生物医学伦理审查体系;开展了临床研究人才全面培训。结论针对深圳开展临床研究的优势与不足,通过政府系统性的规划和顶层设计,建立健全人才培养体系,构建关键的技术平台才能保障临床研究的可持续发展。Objective With the encouragement of Shenzhen government and medical institutions,the investment in clinical research projects is keep increasing,it is urgent to explore the construction of a well-functioning and effective clinical research technical support and supervision system. Methods The unmet needs were obtained and identified by survey and interview at first.The work plan has been made on the basis of the requirements and followed to building the infrastructure.Results The recent actions and achievements for setting up the support and supervision infrastructure have been listed in summary:(1)the government initiated the construction of support system and technical platform for clinical research;(2)set up multiple levels biomedical ethical review board in Shenzhen;(3)conduct comprehensive trainings for clinical research investigators.Conclusions To summarize the advantages and disadvantages of conducting clinical research in Shenzhen,through the systematic planning and top-level design from the government,establish a multidimensional talent training system and construct the technical platform to ensure the sustainable development of clinical research.

关 键 词：临床研究 监管 技术支持平台 

分 类 号：R155.5[医药卫生—营养与食品卫生学]