医疗机构开展新型冠状病毒疫苗临床试验流程探究  

Research on the clinical trial process of corona virus disease 2019 vaccine in medical institutions

作　　者：金志丽[1] 汪颖[1] 尹航[1] 张健雄 李冉 孔艳红[1] 董瑞华 JIN Zhi-li;WANG Ying;YIN Hang;ZHANG Jian-xiong;LI Ran;KONG Yan-hong;DONG Rui-hua(ResearchWard,Beijing Friendship Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京友谊医院研究型病房,北京101149

出　　处：《中国临床药理学杂志》2023年第19期2847-2850,共4页The Chinese Journal of Clinical Pharmacology

基　　金：首都卫生发展科研专项基金资助项目(首发2022-2Z-20215)。

摘　　要：预防用疫苗上市前的临床研究主要在疾病预防控制机构完成,医疗机构(医院)作为主要研究单位在疫苗早期临床试验中的参与度并不高,仅有极少数医疗机构具有开展疫苗临床试验的经验。本文基于首都医科大学附属北京友谊医院开展的3项新型冠状病毒疫苗(以下简称:新冠疫苗)Ⅰ~Ⅲ期临床试验中积累的经验,结合医疗机构实际特点,对疫苗临床试验中场地环境、人员配备、受试者权益保护等方面的质量控制进行分析,旨在探究医疗机构开展新冠疫苗临床试验流程,明确医疗机构开展预防用疫苗上市前临床试验实施过程中的注意事项,提高以医疗机构作为疫苗临床试验主要研究单位的储备能力。The clinical trials of preventive vaccines before marketing are mainly completed in the centers for disease control and prevention.Medical institutions(hospitals),as the main research units,do not have a high degree of participation in the clinical trials of vaccines.Only a few medical institutions have experience in conducting clinical trials of vaccines.Based on the experience accumulated in the recent phaseⅠ-Ⅲclinical trials of three corona virus disease 2019(COVID-19)vaccines carried out by Beijing Friendship Hospital,Capital Medical University,and in combination with the actual characteristics of medical institutions,the quality control of the site,staffing,and protection of rights and interests of subjects in the clinical trials of COVID-19 vaccines were analyzed.The purpose is to explore the process for medical institutions to carry out the clinical trials of COVID-19 vaccine,clarify the precautions for medical institutions to carry out premarketing clinical trials of preventive vaccines,and improve the reserve capacity of medical institutions as the main research units for clinical trials of vaccines.

关 键 词：新型冠状病毒疫苗 医疗机构 临床试验 场地环境 人员配备 受试者权益保护 

分 类 号：R97[医药卫生—药品]