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中国呼吸专业药物临床试验机构备案现状及分析

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目的:了解我国呼吸专业药物临床试验机构及其主要研究者(principal investigator,PI)的备案现状,为我国构建呼吸专业临床研究网络提供参考。方法:通过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,对备案呼吸专业机构情况进行统计分析。备案平台检索时间为建库至2023年3月9日,公示平台检索时间为建库至2022年12月31日。结果:截至2023年3月9日,我国共有771家备案呼吸专业机构,分布于31个一级行政区,呼吸专业PI达3 133人。广东、江苏、河南等备案呼吸专业机构数排名前9位的省份,占全国总数的57。1%;呼吸专业PI区域分布与备案呼吸专业机构分布呈正相关。87。0%的备案呼吸专业机构为三甲医院,93。7%的呼吸专业PI集中于三甲医院。截至2022年12月31日,备案呼吸专业机构中,呼吸临床试验组长单位数排名前10位的省份牵头承接了全国75。7%的临床试验项目。结论:我国呼吸专业机构及PI资源面临横向和纵向发展不平衡等问题,对弱势地区和机构应予以充分动员和重视,为建设呼吸专业临床研究网络奠定基础。
Current status and analysis of registered specialty Respiratory drug clinical trial institutions in China
OBJECTIVE To understand the current registration status of specialty Respiratory drug clinical trial institutions and their principal investigators(PI)in China,to act as a reference for the development of a specialty Respiratory clinical research network in China.METHODS Statistical analysis of the status of registered specialty Respiratory clinical trial institutions was performed through the drug clinical trial institution registration management information platform and the drug clinical trials regis-tration and information publicity platform.The search period was from the date that the registration management platform was built to March 9,2023 and from the date that the publicity platform was built to December 31,2022.RESULTS As of March 9,2023,there were a total of 771 registered specialty Respiratory institutions in China,distributed in 31 first-level administrative regions,with 3 133 specialty Respiratory PI.Guangdong,Jiangsu,Henan and other provinces ranked among the top 9 provinces in terms of the number of registered specialty Respiratory institutions,together accounted for 57.1%of the country's total.The regional distribution of specialty Respiratory PI was positively correlated with the distribution of registered specialty Respiratory institutions.87.0%of the registered specialty Respiratory institutions were third-A hospitals,and 93.7%of specialty Respiratory PI were concentrated in third-A hospitals.As of December 31,2022,among registered specialty Respiratory institutions,the top 10 provinces in terms of the number of specialty Respiratory clinical trial leader units,accounted for 75.7%of the country's Respi-ratory clinical trials.CONCLUSION Specialty Respiratory institutions and PI resources in China face the problems of unbal-anced integration,horizontally and vertically.Disadvantaged regions and institutions need to be encouraged to fully develop,to lay the foundation for building a specialty Respiratory clinical research network.

Respiratorydrug clinical trial institutionsprincipal investigatorsregistration

杨启凡、刘丽宏、赵志霞、王宇萍

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中国医学科学院北京协和医学院群医学及公共卫生学院,北京 100730

中日友好医院药学部,北京 100029

中日友好医院药物临床试验研究中心,北京 100029

呼吸 药物临床试验机构 主要研究者 备案

中国医科院医学与健康科技创新工程项目

2021-I2M-1-045

2024

中国医院药学杂志
中国药学会

中国医院药学杂志

CSTPCD北大核心
影响因子:1.198
ISSN:1001-5213
年,卷(期):2024.44(11)
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