药物临床试验电子知情同意及受试者补助电子发放技术的满意度评价  

Satisfaction evaluation of electronic informed consent and electronic payment of subject compensation in clinical trials

作　　者：黄樱硕[1] 赵连晖 魏巍[3] 左旭 单姗[2] 马红[2] 汪颖[1] 崔焱[4] 尤红[2] 卢鸣 董瑞华 贾继东[2] HUANG Ying-shuo;ZHAO Lian-hui;WEI Wei(Research Ward,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Liver Research Center,Beijing Friendship Hospital,Capital Medical University,Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis,National Clinical Research Center for Digestive diseases,Beijing 100050,China;Clinical Epidemiology and EBM Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院研究型病房,北京100050 [2]首都医科大学附属北京友谊医院肝病中心,肝硬化转化医学北京市重点实验室,国家消化系统疾病临床医学研究中心,北京100050 [3]首都医科大学附属北京友谊医院临床流行病学与循证医学中心,北京100050 [4]首都医科大学附属北京友谊医院生命伦理委员会,北京100050 [5]腾盛博药医药技术(北京)有限公司,北京100192

出　　处：《临床和实验医学杂志》2021年第21期2349-2353,共5页Journal of Clinical and Experimental Medicine

基　　金：肝病创新药物早期临床试验关键技术规范研究(编号:Z191100007619037);国家“十三五”科技重大专项课题名称(编号:2018ZX09201016);北京市研究型病房建设示范单位项目(编号:BCRW202010)。

摘　　要：目的评价2项全国多中心的慢性乙型肝炎创新药临床试验中尝试应用电子知情同意和受试者补助电子发放(2E)技术的满意度。方法参加2项肝病创新药临床试验的受试者及工作人员作为研究对象。分别针对受试者及工作人员设计调查问卷,采用问卷星的形式发放调查问卷,重点针对电子知情同意和受试者补助电子发放的满意度及相关评价进行调查分析。结果上述2个项目的入组受试者中发放25份问卷,回收23份,有效回收率为92.0%;工作人员共发放28份问卷,回收24份,有效回收率为85.7%。申办方、临床协调员、受试者及研究者对2E技术均给予好评,受试者对2E的满意度分别为95.7%和87.0%,工作人员对2E的满意度均为100%。结论与传统知情同意及受试者补助发放相比,受试者及工作人员对2E的整体满意度高;通过扩大2E应用范围和完善功能,可提高临床研究的速度和质量,并使更多的受试者获益。Objective To evaluate the satisfaction of using electronic informed consent and electronic payment of subject compensation(2E)technology in 2 national multi-center clinical trials of innovative drugs for chronic hepatitis B.Methods Subjects and staffs from two clinical trial of innovative drugs for liver disease.Questionnaires were designed for the subjects and the staff respectively.Questionnaires were distributed in the form of Wenjuanxing,and the satisfaction and related evaluation of electronic informed consent and electronic payment of subject compensation were investigated and analyzed.Results A total of 25 questionnaires were distributed to the subjects and 23 were effectively received with effective recovery of 92.0%.A total of 28 questionnaires were distributed to the staffs and 24 were effectively received with effective recovery of 85.7%.The sponsor,the clinical research coordinator,the subjects,and the investigators all praised 2E technology.The subjects'satisfaction rates with 2E were 95.7%and 87.0%,respectively.The staffs'satisfaction rates with 2E were both 100%.Conclusion Compared with conventional informed consent and payment of subject compensation,the overall satisfaction of subjects and staffs to 2E is high.Expanding the application range and improving the function of 2E can improve the efficiency and quality of clinical research and offer more benefit for the subjects.

关 键 词：药物临床试验 电子知情同意 受试者补助电子发放 伦理 满意度 调查问卷 

分 类 号：R197.1[医药卫生—卫生事业管理]