我国临床研究受益评估指标框架的探讨与构建  

Exploration and construction of an evaluation indicator framework for clinical research benefits in China

作　　者：张艾一 陈虎[2] 盛艾娟[3] 白楠[4] 陈燕芬[5] 余中光[6,7] ZHANG Aiyi;CHEN Hu;SHENG Aijuan;BAI Nan;CHEN Yanfen;YU Zhongguang(Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Beijing 100005,China;Discipline Construction Office,Cangzhou Central Hospital,Cangzhou 061017,China;Ethics Office,Beijing You An Hospital,Capital Medical University,Beijing 100069,China;Medical Ethics Office,Chinese People’s Liberation Army General Hospital,Beijing 100039,China;Department of Scientific Research,China-Japan Friendship Hospital,Beijing 100029,China;Respiratory Center,China-Japan Friendship Hospital,Beijing 100029,China;School of Economics and Management,Wuhan University,Wuhan 430072,China)

机构地区：[1]北京协和医院临床药理研究中心,北京100005 [2]沧州市中心医院学科建设办公室,河北沧州061017 [3]首都医科大学附属北京佑安医院伦理办公室,北京100069 [4]中国人民解放军总医院医学伦理办公室,北京100039 [5]中日友好医院科研处,北京100029 [6]中日友好医院呼吸中心,北京100029 [7]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》2024年第4期448-452,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);中日友好医院高水平项目“临床研究风险评估量表开发与应用研究——以呼吸领域项目为例”(2023-NHLHCRF-GLMS-14)。

摘　　要：目的构建临床研究受益评估框架,为临床研究受益评估标准的制定提供参考。方法采用德尔菲法开展专家咨询,并汇总计算评价指标均数、重要性得分、变异系数、协调系数等,筛选临床研究受益评估指标。结果选取了领域内23名专家进行函询,两轮专家积极程度均为100%,权威系数均≥0.90,肯德尔协调系数均<0.25(P<0.001);参考指标均值和变异系数,并结合专家建议,最终形成一级指标2个,二级指标5个,三级指标8个的临床研究受益评估框架。结论构建的临床研究受益评估框架可全面评估研究受益,为合理确定研究风险受益比,以及开发量化的临床研究受益评估工具提供基础。Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall’s coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.

关 键 词：临床研究收益 风险受益 医学伦理 伦理审查 

分 类 号：R-052[医药卫生]