疫苗临床试验现场选择及评估的探讨

Discussion on site selection and evaluation of vaccine clinical trials

疫苗临床试验通常由省级疾病预防控制中心作为负责机构,在市、县级疾病预防控制中心开展实施,为保证疫苗临床试验的质量,省级疾病预防控制中心需建立完善的疫苗临床试验现场选择及评估标准,对现场的硬件设施、软件条件等进行评估。结合湖北省疾病预防控制中心近几年在疫苗临床试验现场选择及评估方面积累的经验,从疫苗临床试验现场选择基本原则及考虑要点、现场评估要点、现场选择及评估中存在的问题几个方面入手,探讨疫苗临床试验研究现场选择及评估要点,以期为国内同行提供借鉴与参考。

Vaccine clinical trials are usually conducted by the provincial centers for disease control and prevention,and carried out in municipal and county-level centers for disease control and prevention.In order to ensure the quality of vaccine clinical trials,the provincial centers for disease control and prevention needs to establish perfect site selection and evaluation standards for vaccine clinical trials,and evaluate the site hardware facilities and software conditions.Based on the experience in the selection of vaccine clinical trial sites in Hubei Provincial Center for Disease Control and Prevention,this paper discusses the key points of vaccine clinical trial research site selection and evaluation from the basic principles of vaccine clinical trial site selection,evaluation points and common problems in site selection and evaluation,in order to provide reference for peers.