摘要
目的 了解我国施行药物临床试验机构备案制前后,江苏省药物临床试验机构的建设情况,分析存在的问题,并提出对策建议。方法 采用查询公共数据和问卷调查的方法,对江苏省药物临床试验机构的发展和现状进行梳理、调查。调查内容包括备案专业、主要研究者、床位、2019—2021年开展项目数量等定量指标。结果 江苏省90家药物临床试验机构主要设置在三级医院。备案数量前3位专业依次是肿瘤科、心血管内科、呼吸内科和神经内科(并列第3位)。近3年全省累计开展试验项目4846个,呈逐年上升趋势。结论 江苏省临床试验机构区域间发展不均衡,试验综合开展水平有待提高。
Objective To understand the construction of drug clinical trial institutions in Jiangsu Province before and after the implementation of the drug clinical trial institution registration system in China,analyze the existing problems,and propose countermeasures and suggestions.Methods By querying public data and conducting a questionnaire survey,the development and current situation of drug clinical trial institutions in Jiangsu were sorted out and investigated.The survey includes quantitative indicators such as registered majors,principal investigators,beds,and the number of projects carried out from 2019 to 2021.Results The 90 drug clinical trial institutions in Jiangsu were mainly set up in tertiary hospitals.The top three majors in terms of registration quantity were oncology,cardiovascular medicine,respiratory medicine and neurology(tied for third place).In the past three years,the province had carried out a total of 4846 trial projects,showing an increasing trend year by year.Conclusion The development of clinical trial institutions in Jiangsu is uneven among regions,and the comprehensive level of trial implementation needs to be improved.
作者
陈颖
丁远锋
周健
林洁
施雯慧
孙志明
CHEN Ying;DING Yuanfeng;ZHOU Jian;LIN Jie;SHI Wenhui;SUN Zhiming(Jiangsu Health Development Research Center,NHC Contraceptives Adverse Reaction Surveillance Center,Jiangsu,Nanjing 210036,China;Jiangsu Commission of Health,Jiangsu,Nanjing 210008,China)
出处
《中国医药科学》
2023年第24期181-184,共4页
China Medicine And Pharmacy
基金
江苏省妇幼健康科研项目(F202038)
江苏省妇幼健康科研项目(F202172)
江苏省卫生健康委科研项目(ZDB2020038)。
关键词
药物临床试验
机构建设
现状
对策
Drug clinical trial
Construction of institution
Current situa tion
Countermeasure
