我国疫苗临床试验开展的现状  

Research of vaccine clinical trial in China

作　　者：夏强 吕亚丽[1,3] 冯文利[1,2] 王淑民 XIA Qiang;Lü Ya-li;FENG Wen-li;WANG Shu-min(Department of Pharmacy,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Office of Drug Clinical Trial Institution,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Office of Institutional Review Board,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100020 [2]首都医科大学附属北京朝阳医院,药物临床试验机构办公室,北京100020 [3]首都医科大学附属北京朝阳医院伦理委员会办公室,北京100020

出　　处：《中国临床药理学杂志》2022年第7期731-734,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的国家鼓励三级医疗机构依法开展疫苗临床试验,但目前开展疫苗临床试验的医疗机构还是少数,处于起步阶段。本文通过综合分析疫苗临床试验开展现状和特点,结合疫苗临床试验相关规章制度和实践经验,建议三级医疗机构开展疫苗临床试验需密切关注机构资质、人员资质、突发事件医疗救治、受试者招募与访视、伦理审查和标准操作规程等方面的特殊要求,在具备条件后实施疫苗临床试验。Objective The government encourages tertiary medical institutions to carry out vaccine clinical trials according to law,but currently there are still a few medical institutions carrying out vaccine clinical trials,which are in the initial stage.By comprehensively analyzing the current situation and characteristics of vaccine clinical trials,combined with relevant regulations and practical experience of vaccine clinical trials,this paper suggested that tertiary medical institutions should pay close attention to the special requirements of institutional qualification,personnel qualification,emergency medical treatment,subject recruitment and visit,ethical review and standard operating procedures before carrying out vaccine clinical trials,and implement vaccine clinical trials when conditions are met.

关 键 词：疫苗 临床试验 三级医疗机构 资质 

分 类 号：R97[医药卫生—药品]