英、德、法三国临床试验风险评估工具的比较研究  

Comparative Study on Risk Assessment Tools for Clinical Trials in England,Germany and France

作　　者：郤思远 张艾一 马寅 赫军[1] 安峥[4] 余中光[4,5] XI Siyuan;ZHANG Aiyi;MA Yin;HE Jun;AN Zheng;YU Zhongguang(Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Faculty of Biomedicine,Beijing City University,Beijing 100094,China;Beijing Ditan Hospital Shunyi Branch,Beijing 101399,China;Center for Respiratory,China-Japan Friendship Hospital,Beijing 100029,China;School of Economics and Management,Wuhan University,Wuhan 430072,China)

机构地区：[1]中日友好医院药学部,北京100029 [2]北京城市学院生物医药学部,北京100094 [3]北京地坛医院顺义分院,北京101399 [4]中日友好医院呼吸中心,北京100029 [5]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4期434-437,共4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：临床试验风险评估对于提高临床试验质量具有重要意义。通过系统比较分析英、德、法三国临床试验风险评估工具,发现三国风险评估工具在法律制度保障与评估流程方面具有一致性,但在临床试验的基础风险分类、风险分级标准方面存在明显差异。在借鉴英、德、法三国经验基础上,提出应从中国国情角度出发,完善临床试验风险管理相关法规文件,并深入研究临床试验风险影响因素,并根据学科特点,开发和设计具有不同学科特色的临床试验风险评估工具,以提高临床试验质量与水平。Risk assessment of clinical trials is of great significance to improve the quality of clinical trials.Through systematic comparative analysis of risk assessment tools for clinical trials in Britain,Germany and France,this paper found that the three countries risk assessment tools were consistent in terms of legal system guarantee and assessment process,but there were obvious differences in the basic risk classification and risk grading standards of clinical trials.Based on the experience of Britain,France and Germany,this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions,further explore the factors affecting clinical trial risk,and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.

关 键 词：临床试验 风险评估工具 风险管理 比较研究 

分 类 号：R197.3[医药卫生—卫生事业管理]