南京市药物临床试验开展现状研究  

Current Status of Development of Drug Clinical Trials in Nanjing

作　　者：马曾庆 林玉 张红 吴连平 史红军 MA Zengqing;LIN Yu;ZHANG Hong;WU Lianping;SHI Hongjun(Nanjing Gaochun People's Hospital,Nanjing,Jiangsu,China 211300)

机构地区：[1]南京市高淳人民医院,江苏南京211300

出　　处：《中国药业》2024年第20期22-26,共5页China Pharmaceuticals

基　　金：南京市高淳人民医院新技术新项目[GXY-2021-015]。

摘　　要：目的了解南京市药物临床试验开展现状。方法查询药物临床试验机构备案管理信息平台、药物临床试验登记与信息公示平台及南京市卫生健康委员会官方网站,获取并汇总南京市2023年登记的药物临床试验相关信息,从备案专业、临床试验开展情况、试验药物情况等方面进行分析。结果2023年南京市共有28家药物临床试验机构、45个专业、985名主要研究者完成备案,均居江苏省首位。医疗机构类别以综合医院为主(14家,50.00%),级别以三级甲等医院为主(21家,75.00%)。共开展药物临床试验项目759项,以Ⅱ期、Ⅲ期药物临床试验为主(82.74%)。试验药物主要类型为化学药物(57.18%),主要剂型为注射剂(53.49%),适应证主要为肿瘤(30.83%)。南京市该领域存在的主要问题包括临床试验机构区域分布不均匀(城区间差距过大),药物临床试验优势资源利用不充分(各机构担任国际、国内多中心试验组长单位次数较少),治疗领域同质化(集中于抗肿瘤)等。结论建议改善地区失衡,合理配置资源;建设培训体系,加快人才培养;开展(多中心临床试验)伦理协作审查,促进审查结果互认;建设高水平国内顶尖学科;大力发展稀缺专业;鼓励开展中药/天然药物临床试验等手段;以此推动南京市药物临床试验竞争力迈上新台阶。Objective To understand the current status of development of drug clinical trials in Nanjing.Methods The relevant information of drug clinical trials registered in Nanjing in 2023 was obtained and summarized from the three websites(https://beian.cfdi.org.cn/CTMDS/apps/pub/drugPublic1.jsp,http://www.chinadrugtrials.org.cn/index.html,http://wjw.nanjing.gov.cn/)to analyze the filing speciality,clinical trial progress and experimental drug.Results There were 28 drug clinical trial institutions,45 specialities,and 985 principlal investigators(PIs)completing filing in Nanjing in 2023,all ranking the first in Jiangsu.The medical institutions were mainly general hospitals(14 institutions,50.00%)and grade-A tertiary hospitals(21 institutions,75.00%).A total of 759 drug clinical trial projects were conducted,mainly in phasesⅡandⅢ(82.74%).The experimental drugs mainly involved chemical drugs(57.18%)and injections(53.49%),with indications mainly for tumors(30.83%).The main problems in this field in Nanjing included uneven distribution of clinical trial institutions(large differences between the urban areas),insufficient utilization of advantageous resources in drug clinical trials(few times of institutions serving as leaders of international and domestic multi-center trial team),and homogenization of therapy areas(mainly in anti-tumor therapy).Conclusion To promote the development of drug clinical trials in Nanjing,it is suggested that we should improve regional imbalance and allocate resources rationally,establish training system and accelerate talent cultivation,conduct ethical collaboration reviews for multi-center clinical trials to promote mutual recognition of review,build high-level domestic top disciplines,vigorously develop scarce specialities,and encourage the development of clinical trials of traditional Chinese medicine/natural medicines.

关 键 词：药物临床试验 医疗机构 南京市 备案登记 多中心试验 

分 类 号：R95[医药卫生—药学]