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陕西省药物临床试验机构现状分析

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目的 了解备案制实施后,陕西省内药物临床试验机构的现状.方法 从药物临床试验机构备案管理信息平台和药物临床试验登记与信息公示平台收集陕西省药物临床试验机构相关数据,从机构发展、地域分布、备案专业、主要研究者、承接项目数量等方面进行统计分析.结果 备案制实施以来,陕西省药物临床试验机构数量增至42家,增幅为110.0%,且主要分布在西安、咸阳、汉中、宝鸡、延安、安康;备案专业由82个增至158个,增幅为92.68%;承接药物临床试验项目由910项增至2173项,增幅为138.79%;各临床机构累计接受各类监督检查66次,直接通过率为60.61%.结论 备案制实施后,陕西省药物临床试验机构发展形势良好,但存在资源分配不均、研究人员能力水平参差不齐、Ⅰ期临床研究平台相对匮乏等情况,应进一步整合临床研究资源、储备临床试验专业人才,全面提升我省临床试验规范化水平.
Current situation of drug clinical trial institutions in Shaanxi province
Objective To understand the current situation of drug clinical trial institutions in Shaanxi province after the implementation of registration system.Methods Data related to drug clinical trial institutions of Shaanxi province were collected from the Drug Clinical Trial Institutions Registration System and the Drug Clinical Trial Registration and Information Disclosure Platform.We systematically analyzed the institutional development,geographical distribution,speciality for recording,principal investigators,and number and stages of drug clinical trials.Results After the impleentation of registration system,the number of drug clinical trial institutions in Shaanxi province increased to 42,with an increase of 110.0%,and the registration institutions were mainly located in Xi'an,Xianyang,Hanzhong,Baoji,Yan'an and Ankang.The number of recorded specialties increased from 82 to 158,with an increase of 92.68%.The number of registered drug clinical trials increased from 910 to 2173,with an increase of 138.79%.Cinical trial institutions received 66 various inspections,with a first time passing rate of 60.61%.Conclusion After the implementation,drug clinical trial institutions develop well in Shaanxi province,but problems exist such as uneven distribution of resources and professional levels of researchers,shortage of phase Ⅰ clinical research platforms,etc..It is necessary to further integrate clinical research resources,reserve clinical trial professionals,and improve the standardization of clinical trials.

institution registration systemdrug clinical trial institutionsituation analysis

张娟利、刘美佑、樊婷婷、张迪、周军红、王婧雯、文爱东

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空军军医大学第一附属医院药剂科,西安 710032

陕西省药品技术审核查验中心,西安 710065

机构备案制 药物临床试验机构 现状分析

西京医院学科助推计划项目

XJZT18D07

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(2)
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