新型冠状病毒肺炎疫情防控常态化下Ⅰ期临床试验开展的实践与思考  

Practice and thinking of phase Ⅰ clinical trials under normalization of COVID-19 prevention and control

作　　者：戴伊歆 徐平声[1,2] 李筱旻[1] 刘万里[1] 潘静[1] 呼晓雷[1] DAI Yi-xin;XU Ping-sheng;LI Xiao-min;LIU Wan-li;PAN Jing;HU Xiao-lei(Phase Ⅰ Clinical Research Center,Xiangya Hospital Central South University,Changsha HUNAN 410008;National Clinical Research Center for Geriatric Disorders,Xiangya Hospital Central South University,Changsha HUNAN 410008)

机构地区：[1]中南大学湘雅医院Ⅰ期临床试验研究中心,湖南长沙410008 [2]中南大学湘雅医院国家老年疾病临床医学研究中心,湖南长沙410008

出　　处：《中国新药与临床杂志》2022年第12期738-742,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：湖南省自然科学基金(2020JJ9022)。

摘　　要：随着我国“外防输入,内防反弹”总策略和“动态清零”总方针的持续落实,新型冠状病毒肺炎疫情防控已进入常态化。如何在疫情防控常态化的当下,安全高效的开展Ⅰ期临床试验是当前各研究机构亟待解决的问题。本文结合本院实践,对疫情防控常态化下Ⅰ期临床试验开展过程中各个环节要点和风险进行梳理与探讨,以期为疫情防控常态化下Ⅰ期临床试验的开展提供借鉴和参考。With the continuous implementation of the“preventing both inbound cases and domestic resurgence”strategy and“dynamic zero-COVID policy”in China,the prevention and control of COVID-19 have entered normalization.It is an urgent issue to be solved how to carry out phase Ⅰ clinical trials safely and efficiently under the current normalization of COVID-19 prevention and control.In order to provide a reference for the development of phase Ⅰ clinical trials,we combed and discussed the key points and risks of phase Ⅰ clinical trials under the normalization of COVID-19 prevention and control based on the practice of our hospital.

关 键 词：新型冠状病毒肺炎 临床试验 Ⅰ期 质量控制 

分 类 号：R969[医药卫生—药理学]