新型冠状病毒肺炎疫情对在研临床试验的影响及应对措施建议  

Impact of the COVID-19 epidemic on ongoing clinical trials and suggestions for countermeasures

作　　者：李会娟[1] 王美容[1] 伦碧汀 武阳丰[1] LI Huijuan;WANG Meirong;LUN Biting;WU Yangfeng(Peking University Clinical Research Institute,Beijing 100191,P.R.China)

机构地区：[1]北京大学临床研究所,北京100191

出　　处：《中国循证医学杂志》2020年第8期871-877,共7页Chinese Journal of Evidence-based Medicine

摘　　要：新型冠状病毒肺炎(COVID-19)是当前全球面临的重大公共卫生事件。因临床试验的场地主要在医疗机构,研究者也主要是临床医生,COVID-19疫情将不可避免地对正在开展的大量临床试验造成巨大影响。临床试验关键环节的实施和关键数据的质量会对临床试验结果的真实性产生较大影响。本文从受试者筛选入组、随机分配、盲法、干预措施的实施、主要终点随访、安全性监测及项目管理等7方面逐一分析新发突发重大传染病疫情对临床试验的潜在影响,并针对性地建议应对措施。Coronavirus disease(COVID-19)is currently a world-wide major public health event.Since study sites of clinical trials are primarily at healthcare institutions and investigators are primarily clinicians,the epidemic inevitably has a huge impact on a large number of ongoing clinical trials.The proper implementation of clinical trials in key aspects and the quality of core data collection will greatly influence the validity of the final results.In this paper,we analyzed the potential impact of the outbreak of a new epidemic infectious diseases on the clinical trials from seven aspects,which involves the selection of study participants,randomization,blinding,implementation of intervention measures,follow-up of primary outcomes,safety monitoring and project management.Corresponding countermeasures were put forward.

关 键 词：新型冠状病毒肺炎 临床试验 影响 应对措施 

分 类 号：R197.6[医药卫生—卫生事业管理]