新型冠状病毒(COVID-19)疫苗临床试验监督核查模式与时机的思考与探索  

Thoughts on supervision and verification model of the clinical trials of COVID-19 vaccine

作　　者：储藏 王伯阳 高锦 于蒙蒙 何为[1] 周苏萍[1] 朱荣鑫 CHU Cang;WANG Bo-yang;GAO Jin;YU Meng-meng;HE Wei;ZHOU Su-ping;ZHU Rong-xin(General Station for Drug&Instrument Supervision and Control Joint Logistic Support Force,Chinese People's Liberation Army,Beijing 100071,China;Health Service Bureau Joint Logistic Support Force,Chinese People's Liberation Army,Wuhan 430014,China)

机构地区：[1]中国人民解放军联勤保障部队药品仪器监督检验总站,北京100071 [2]中国人民解放军联勤保障部队卫勤局,湖北武汉430014

出　　处：《中国药物应用与监测》2020年第4期269-271,共3页Chinese Journal of Drug Application and Monitoring

摘　　要：针对类似新冠病毒肺炎等特别重大突发公共卫生事件,建立治疗药品和预防疫苗临床试验同步全程的现场监督核查模式。回顾性总结分析实施同步全程现场监督核查模式新冠疫苗Ⅰ期临床试验的特殊背景、监督重点和监督意义,并比较分析与常规监督核查的不同之处。在特别重大突发公共卫生事件治疗药品、预防疫苗临床试验监督核查中,有必要根据国家疫苗管理的相关法规制度,启动同步全程监督核查机制,以保证应急状态下的临床试验质量,落实“四个最严”监督理念并最大程度保障受试者健康权益。To establish the whole course and synchronous supervision and verification model of clinical trials for particularly major public health emergencies just like COVID-19.The special background,supervision focus and supervision significance of using the whole course and synchronous supervision and verification model to supervise the phase I clinical trials of COVID-19 vaccine were retrospectively summarized and analyzed.And the differences between the whole course and synchronous supervision and verification model as well as the general supervision and verification model were also clarified in this study.In the supervision and verification of drugs and clinical trials of vaccine for particularly major public health emergencies,it was necessary to start the whole course and synchronous supervision and verification model based on the relevant laws and regulations of vaccine management in order to ensure the quality of clinical trials under emergency conditions,fulfil the supervision concept of"the four strictest",and guarantee the interests of subjects as possible as we could.

关 键 词：新型冠状病毒 疫苗 临床试验 监督 模式 

分 类 号：R969.3[医药卫生—药理学]