基于高效团队理论的药物临床试验团队建设实践初探

Discussion on the practice of drug clinical trial team building based on the theory of high-performance team

基于国家对药物临床试验机构监管方式从资格认定改为备案管理,越来越多的医疗机构通过备案获得开展药物临床试验的资质。传统以质量控制为主的临床试验管理方式存在滞后性,医疗机构须加强对自身药物临床试验专业的建设,高效临床试验团队成为提升机构竞争力和新药临床试验风险控制的首要措施。本文基于高效团队理论,对药物临床试验团队存在的问题进行分析,提出高效临床试验团队建设方法。

Based on the change of the national supervision method for drug clinical trial institutions from qualification recognition to filing management,more and more medical institutions have obtained the qualification to carry out drug clinical trials through filing.There is a lag in the traditional quality control-based clinical trial management method,so medical institutions must strengthen the construction of their own drug clinical trials.Efficient clinical trial teams have become the primary measures to enhance the competitiveness of institutions and the risk control of new drug clinical trials.Based on the theory of high-performance teams,this paper analyzes the problems existing in drug clinical trial teams and proposes a method of efficient clinical trial team building.