基于风险的综合性医院生物制品药物临床试验管理难点剖析  

Analysis of Difficulties in the Management of Clinical Trials of Biological Products in General Hospital Based on Risk

作　　者：鲁萌[1] 朱静静[1] 戴建[1] 朱晓芳[1] 王健[1] Lu Meng;Zhu Jingjing;Dai Jian;Zhu Xiaofang;Wang Jian(National Drug Clinical Trial Institution of Affiliated Drum Tower Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院国家药物临床试验机构,南京210008

出　　处：《中国药师》2020年第11期2235-2238,共4页China Pharmacist

摘　　要：目的:探讨基于风险的综合性医院生物制品药物临床试验的规范化管理。方法:从项目数量、科室分布、严重不良事件统计三个方面评估我院生物制品药物临床试验的管理现状,并从受试者依从性管理、药物管理、盲态维持、发生不良事件四个风险点进行风险因素分析,将风险管理加入到质量管理中,探讨降低风险事件发生率或影响的方法。结果:机构采取储备受试者、提高对受试者的健康宣教;推进临床试验用药物中心化管理;重视对盲态和非盲态人员的培训;及时处理不良事件等降低风险的应对措施来进行风险控制。结论:我院建立并完善生物制品药物临床试验风险管理体系。保障生物制品药物临床试验的顺利开展和数据的真实完整,提高临床试验机构的管理水平。Objective:To discuss risk-based standard management of clinical trials of biological products in general hospitals.Methods:The management status of clinical trials of biological products in our hospital was evaluated from three aspects:the number of projects,the distribution of departments and the statistics of serious adverse events.Risk factors were analyzed from four risk points:subject compliance management,drug administration,keeping blind state and occurrence of adverse events.Risk management was added to the quality management to explore ways to reduce the incidence or influemce of risk events.Results:The institution adopted measures to reduce risks such as reserving subjects,improving health education for subjects,promoting centralized management of drugs for clinical trials,paying attention to the training of blind and non-blind personnel,and dealing with adverse events in time.Conclusion:In order to guarantee the development of clincal trials of biological products and the authenticity and completeness of data,our hospital established and improved the risk management system for clinical trials of biological products,and as a result,the management level of clinical trial institution was improved.

关 键 词：生物制品 药物临床试验 风险管理 项目管理 

分 类 号：R95[医药卫生—药学]