基于文献分析的我国药物临床试验风险影响因素研究  

Research on Influencing Factors of Drug Clinical Trial Risks in China Based on Literature Analysis

作　　者：张艾一 郤思远 安峥[3] 余中光[3,4] ZHANG Aiyi;XI Siyuan;AN Zheng;YU Zhongguang(Department of Biomedicine,Beijing City University,Beijing 100094,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Center of Respiratory,China-Japan Friendship Hospital,Beijing 100029,China;School of Economics and Management,Wuhan University,Wuhan 430072,China)

机构地区：[1]北京城市学院生物医药学部,北京100094 [2]中日友好医院药学部,北京100029 [3]中日友好医院呼吸中心,北京100029 [4]武汉大学经济与管理学院,湖北武汉430072

出　　处：《中国医学伦理学》2023年第6期613-617,共5页Chinese Medical Ethics

基　　金：国家自然科学基金青年基金项目“临床研究伦理审查风险与受益评估指标体系研究”(72104255);中国医学科学院医学与健康科技创新工程项目“基于卫生健康体系学的健康中国建设战略研究”(2021-I2M-1-046)。

摘　　要：目的为梳理药物临床试验风险影响因素,提高中国药物临床试验风险管理水平。方法采用文献分析法梳理中国药物临床试验风险管理相关文献,采用文本分析法总结和提炼了药物临床试验的风险影响因素。结果药物临床试验风险类别分为5大类,即药物临床试验机构管理、伦理委员会管理、临床试验设计、研究者、受试者,涉及主要风险影响因素13项,具体风险点21项。结论加强药物临床试验机构与伦理管理能力建设,优化研究方案设计,提高研究者意识与能力,建立受试者管理体系,通过上述举措改进药物临床试验质量。Objective:To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China.Methods:The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China,and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks.Results:The risk categories of drug clinical trials were divided into 5 parts,namely drug clinical trial institution management,ethics committee management,clinical trial designs,researchers,and subjects,involving 13 main risk influencing factors and 21 specific risk points.Conclusion:By strengthening the construction of drug clinical trial institutions and ethical management capabilities,optimizing research protocol design,enhancing researchers awareness and ability,and establishing a subject management system to improve the quality of drug clinical trials.

关 键 词：药物临床试验 风险识别 风险管理 文献分析 

分 类 号：R-05[医药卫生]