江西省药物临床试验机构建设和管理调查分析  

Analysis on the Construction and Development Status of Drug Clinical Trial Institutions in Jiangxi Province

作　　者：程晓华[1] 林莉 朱慧婷[3] CHENG Xiaohua;LIN Li;ZHU Huiting(Clinical Trial Center,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Drug Registration Office,Jiangxi Provincial Drug Administration,Nanchang 330029,China;Office of Drug Clinical Trial Institutions,Jiangxi Provincal Children's Hospital,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院临床试验中心,南昌330006 [2]江西省药品监督管理局药品注册处,南昌330029 [3]江西省儿童医院药物临床试验机构办公室,南昌330006

出　　处：《医药导报》2025年第5期829-833,共5页Herald of Medicine

基　　金：江西省卫生健康委科技计划项目(202310302);江西省药品监督管理局科研项目(2021KY06)。

摘　　要：目的调研和分析江西省药物临床试验机构建设和管理现状,为机构规范管理和发展提供参考。方法选取“药物和医疗器械临床试验机构备案管理信息系统”中江西省已备案的药物临床试验机构为研究对象,采用检索公开数据及以“问卷星”形式推送问卷至备案医疗机构收集问卷数据,从多个维度对药物临床试验机构建设与管理的数据进行描述性分析。结果截至2023年12月,江西省已完成备案的药物临床试验机构52家,疫苗临床试验机构1家,备案机构的组织管理架构、人员组成和软硬件均基本符合开展药物临床试验的基本要求。近年来,药物临床试验备案机构数以及承接项目数逐年上升,临床试验机构管理能力和综合实力不断增强,但较医药产业发达地区仍存在较大差距。结论江西省备案的药物临床试验机构间存在区域发展不均衡、不同机构间项目承接能力参差不齐、临床试验信息化管理程度不高、临床试验综合能力有待提升等问题。Objective To investigate and analyze the construction and management status of drug clinical trial institutions in Jiangxi Province,and to provide a reference for institutions'standardized management and development.Methods The registered drug clinical trial institutions in Jiangxi Province were selected as the research objects in the"Drug and Medical Device Clinical Trial Institution Filing Management Information System",and the public data were retrieved.Questionnaires were sent to the registered medical institutions as"Questionnaire Star"to collect the questionnaire data.The data on the construction and management of drug clinical trial institutions were analyzed descriptively from multiple dimensions.Results By December 2023,52 drug clinical trial institutions and one vaccine clinical trial institution had been registered in Jiangxi Province.The organization and management structure,personnel composition,hardware,and software of the registration institutions met the basic requirements for conducting drug clinical trials.In recent years,the number of drug clinical trial record institutions and the number of projects to undertake has increased year by year,and the management ability and comprehensive strength of clinical trial institutions have been continuously enhanced,and there is still a big gap compared with the developed areas of the pharmaceutical industry.Conclusion There is unbalanced regional development,uneven ability of different institutions to undertake projects,a low level of clinical trial information management,and the comprehensive ability of clinical trials needs to be improved in Jiangxi Province.

关 键 词：临床试验 备案制 药物临床试验机构 运行与管理 

分 类 号：R95[医药卫生—药学]