全国联网临床研究志愿者数据库建设与效果分析  

Construction of the National Networked Clinical Research Volunteer Database and effect analysis

作　　者：韩帅玮琦 赵侠[1,2] 周颖[1,2] 刘泽源[3] 江骥 陈筱 刘立新 顾金辉[6] 崔一民 HAN Shuai-wei-qi;ZHAO Xia;ZHOU Ying;LIU Ze-yuan;JIANG Ji;CHEN Xiao;LIU Li-xin;GU Jin-hui;CUI Yi-min(Department of Pharmacy Administration&Clinical Pharmacy,School of Pharmaceutical Science,Peking Unitersity,Beijing 100191,China;Department of Pharmacy,Peking University First Hospital,Bejying 100034,China;Department of Clinical Pharmacology,The Fifth Medical Centre,Chinese PLA People's Liberation Army General Hospital,Beijing 100071,China;Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Bejing 100032,China;Bejing Farinfo Technology Co.Ltd,Beijing 100085,China;Department of Medical Science,Technology and Education,National Health Comission of the People’s Republic of China,Bejing 100044,China;Institution of Clinical Pharmacology,Pehing University,Bejing 100191,China)

机构地区：[1]北京大学药学院药事管理与临床药学系,北京100191 [2]北京大学第一医院药学部,北京100034 [3]中国人民解放军总医院第五医学中心临床药理室,北京100071 [4]中国医学科学院北京协和医院临床药理研究中心,北京100032 [5]北京中兴正远科技有限公司,北京100085 [6]国家卫生健康委员会科技教育司,北京100044 [7]北京大学临床药理研究所,北京100191

出　　处：《中国临床药理学杂志》2020年第13期1879-1883,共5页The Chinese Journal of Clinical Pharmacology

基　　金：“重大新药创制”科技重大专项基金资助项目(2017ZX09101001-002-003)。

摘　　要：目的建设推广全国联网的健康志愿者数据库,采用数据筛查机制以期解决我国部分健康志愿者不遵照临床试验方案规定间隔期参与试验的问题,为未来健康志愿者管理和构建包含以患者为受试者的所有临床研究的人口学联网筛查机制提供依据。方法介绍全国联网临床研究志愿者数据库(联网数据库)的建设历程,研究搭建联网数据库核心技术路线和逻辑架构,调研分析联网数据库自2015-1-1至2019-12-31期间的运营数据。结果截至2019-12-31,全国共计268个临床试验机构安装使用联网数据库。2015-1-1至2019-12-31,联网数据库内共计注册6143项临床试验,筛查256219名健康志愿者,产生556725人次的筛查记录,其中入组试验172581人次,入组比例为31.00%。志愿者男女比例约为7:3,首次接受筛查时60.16%的志愿者年龄在19~30周岁,志愿者户籍来源前3位的地区为河南、湖南、吉林。联网数据库对不符合临床试验筛选要求志愿者的拦截(冲关)人数为17959人,占全部志愿者的7.01%,共计产生了28994人次的冲关记录。每年冲关人次占筛选总人次的比例从2015年的12.20%下降到2019年的3.93%,同期平均每人冲关次数从2.38次下降到1.29次。结论使用联网数据库后效果明显,健康志愿者的冲关意愿明显降低,大幅减少了不符合临床试验筛选要求的志愿者参与试验的概率和次数,能有效保证志愿者人身安全和试验质量。Objective To construct and promote a nationwide network of healthy volunteer databases,and use a data screening mechanism to solve the problem that some healthy volunteers in China do not follow the clinical trial protocol to participate in trials at intervals.The demographic networking screening mechanism for all clinical studies of the subjects provided the basis.Methods Introduce the construction process of the National Networked Clinical Research Volunteer Database(Networked Database),study the core technical route and logical architecture of the networked database,and investigate and analyze the operational data of the networked database from January 1,2015,to December 31,2019.Result As of December 31,2019,a total of 268 clinical trial institutions across China have installed and used networked databases.From January 1,2015,to December 31,2019,a total of 6,143 clinical trials were registered in the networked database,and 256,219 healthy volunteers were screened,resulting in a screening record of 556,725 person-times,of which 172,581 person-times were included in the trials,and the proportion of participants Is 31.00%.The ratio of volunteers to men and women is about 7∶3.At the time of first screening,60.16%of volunteers were aged 19-30.The top 3 regions for the sources of volunteer household registration were Henan,Hunan,and Jilin.The networked database intercepted 17,959 volunteers who did not meet the clinical trial’s screening requirements,accounting for 7.01%of all volunteers.A total of 28,994 interceptions were recorded.The proportion of intercepted people per year in the total screening decreased from12.20%in 2015 to 3.93%in 2019.During the same period,the average number of interceptions per person decreased from 2.38 to 1.29.Conclusion The effect of using the networked database is noticeable,and the willingness of healthy volunteers to reduce customs is significantly reduced,which significantly reduces the probability and number of volunteers who do not meet the screening requirements of clinical

关 键 词：临床试验 健康志愿者 志愿者联网数据库 志愿者管理 

分 类 号：R97[医药卫生—药品]