Ⅰ期临床试验中试验用疫苗管理模式的探讨  

Study on the management model of experimental vaccine in phaseⅠclinical trial

作　　者：陆瑶[1] 曹钰然[1] 詹惠中 李彩红 王斌 吴翠云[2] 伍蓉[2] 曹国英[1] 张菁[1] LU Yao;CAO Yu-ran;ZHAN Hui-zhong;LI Cai-hong;WANG Bin;WU Cui-yun;WU Rong;CAO Guo-ying;ZHANG Jing(Office of Drug Clinical Trials Institution,Huashan Hospital,Fudan University,Shanghai 200040,China;Institutional Review Board,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院,药物临床试验机构办公室,上海200040 [2]复旦大学附属华山医院,伦理审查委员会,上海200040 [3]复旦大学附属华山医院,药剂科,上海200040

出　　处：《中国临床药理学杂志》2021年第15期2077-2078,2085,共3页The Chinese Journal of Clinical Pharmacology

基　　金：科技部“重大新药创制”科技重大专项基金资助项目(2017ZX09304005);上海市促进市级医院临床技能与临床创新能力三年行动计划资助项目(20CR4002B)。

摘　　要：疫苗因来源于活生物体、组成复杂,比常规试验用药品管理的要求更加严格。本文基于近期本院开展的1项新型冠状病毒肺炎(COVID-19)疫苗Ⅰ期临床试验中积累的试验用疫苗管理经验,从试验用疫苗的接收、保存、分发、回收、返还和疫苗损毁的处理流程这几个关键点入手,分析探讨试验用疫苗的管理模式。Vaccines,because they are derived from living organisms and are complex in composition,have more stringent regulatory requirements than conventional experimental drugs based on the experience accumulated during the implement of a phase I clinical trial of the corona virus disease 2019(COVID-19)vaccine conducted by our hospital,this paper analyzed and discussed the management mode of experimental vaccine from the key points of receiving,storing,distributing,recycling,returning,and handling of damaged vaccine.

关 键 词：新型冠状病毒肺炎 疫苗 临床试验 管理 

分 类 号：R97[医药卫生—药品]