摘要
目的分析我国开展的新型冠状病毒肺炎(简称“新冠肺炎”)临床试验的特点,发现可能存在的问题,为临床试验设计者及政策制定者提供一定的参考。方法收集2020年2月23日24点之前在中国临床试验注册中心官网和美国ClinicalTrials.gov官网注册的新冠肺炎临床试验数据,使用DDA软件进行数据清洗,采用SPSS 18.0对临床试验各特征变量进行描述。结果我国第1项新冠肺炎临床试验注册时间为2020年1月23日,截至2020年2月23日24点我国共注册240项新冠肺炎临床试验,其中多中心研究62项(25.83%)。共有157个机构参与临床试验,其中医疗机构最多(122个),参与机构地理分布前5名依次为北京、湖北、广东、浙江、上海。临床试验参与患者的年龄主要以成年人(15~64岁)/老年人(≥65岁)为主(63.75%),研究类型主要以干预性研究为主(75.42%),干预措施主要以药物为主(68.51%),经费来源主要以自筹为主(25.00%)。181项干预性研究所处阶段以0期(70项)和Ⅳ期(49项)为主。结论目前我国开展的临床试验数量多,但机构合作较少,干预措施和试验药物种类不聚焦,招募人数不尽合理,参与机构及经费来源多样化。
Objective To analyze characteristics of clinical trials of coronavirus disease 2019(COVID-19)in China,find out possible problems,and provide reference for clinical trial designers and policy makers.Methods Clinical trial data for CONID-19 registered at official website of China Clinical Trial Registry and U.S.ClinicalTrials.gov before 24:00 on February 23,2020 were collected,data were cleaned by Ducati Data Analyzer(DDA)software,and characteristic variables of clinical trials were described by SPSS 18.0.Results The first COVID-19 clinical trial registration date was on January 23,2020,by the end of 24:00 of February 23,2020,China has registered 240 COVID-19 clinical trials,including 62(25.83%)multi-center studies.A total of 157 institutions participated in the clinical trials,with the largest number of medical institutions(n=122),and the top five geographical distribution of participating institutions were in Beijing,Hubei,Guangdong,Zhejiang and Shanghai.The main age of patients recruited in the clinical trial were adults(15-64 years old)/the elderly(≥65 years old)(63.75%),the main type of research was intervention study(75.42%),the main intervention measure was drugs(68.51%),the main source of funding was self-financing(25.00%).181 intervention studies were at stage 0(n=70)andⅣ(n=49).Conclusion At present,there are a large number of clinical trials in China,but there are few institutional cooperation,the types of intervention measures and trial drugs are not focused,the number of recruits is irrational,and the participating institutions and funding sources are diversified.
作者
殷环
张婷
李陈晨
张越伦
高东平
YIN Huan;ZHANG Ting;LI Chen-chen;ZHANG Yue-lun;GAO Dong-ping(Health Science and Technology Strategic Information Research Office,Institute of Medical Information&Library,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100020,China;Medical Device and Drug Strategic Intelligence Research Office,Institute of Medical Information&Library,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100020,China;Telemedicine Center of the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;National Engineering Laboratory for Internet Medical Systems and Applications,Zhengzhou 450052,China;Medical Science Research Center of Peking Union Medical College Hospital,Beijing 100730,China)
出处
《中国感染控制杂志》
CAS
CSCD
北大核心
2020年第8期671-678,共8页
Chinese Journal of Infection Control
基金
中国医学科学院医学与健康科技创新工程重大协同创新项目(2016-I2M-2-004)。
作者简介
通讯作者:殷环(1989-),女(汉族),湖北省随州市人,助理研究员,主要从事医学信息学、医学科技管理、医学科技资源配置相关政策研究,E-mail:yin.huan@imicams.ac.cn。
