基于PICO对ICTRP注册的新型冠状病毒肺炎临床试验分析

ICTRP-registered COVID-19 Clinical Trials Based on PICO

目的:分析和总结关于新型冠状病毒肺炎(Corona Virus Disease 2019,COVID-19)的临床试验在国际临床试验注册平台(international clinical trials registry platform,ICTRP)上的注册情况,为COVID-19的临床试验开展及防治提供参考。方法:检索2020年1月1日至2020年3月20日在ICTRP注册中心注册的关于COVID-19的临床试验。基于PICO模式采集、分析信息,对试验的申报单位、研究现场、研究类型等进行分析总结。结果:共检索到522项临床试验。申报单位和研究现场均集中在湖北等疫情严重地区和广东、浙江等经济发达和科研实力较强的地区,其中湖北注册数量和研究现场排名第一。522项临床试验以干预性试验为主。按学科分布把522个试验分3类:西医类试验占68%(356/522),中西医结合类占25%(132/522),心理+行为干预类占7%(34/522)。结论:我国医学家的临床研究意识和能力都得到了很大的提升,但仍存在地区分布差距大、中医药类临床试验较少等问题,需要进一步规范并提高。

Objective:To analyze and summarize the registration status of COVID-19 on ICTRP,so as to provide the reference for the launch of clinical trials for COVID-19,as well as its prevention and treatment.Methods:Clinical trials on COVID-19 were retrieved from January 1st,2020 to March 20th,2020 in ICTRP registry.After gathering and analyzing the information based on PICO model,the applicants,research site and research type of the trials were analyzed and concluded.Results:All 522 clinical trials have been searched.The applicants and research sites are concentrated in severely affected areas such as Hubei province and economically developed and strong scientific research areas such as Guangdong and Zhejiang province,among which,the number of registrations and research sites in Hubei ranked first.Intervention tests were predominant among the 522 clinical trials.All 522 clinical trials could be classified into three types according to subject distribution:the trials of Western medicine,68%(356/522),the ones of integrated Chinese and Western medicine,25%(132/522),as well as psychology+behavior intervention type,7%(34/522).Conclusion:The doctors'awareness and capacity of clinical research in China have been greatly improved,but there are still some problems such as large regional distribution gap and few TCM clinical trials,which need to be further standardized and improved.