中国药业2026，Vol.35Issue(7)：23-28,6.DOI:10.3969/j.issn.1006-4931.2026.07.004
湖北省药物临床试验机构备案制实施后发展现状分析
Current Development Status of Drug Clinical Trial Institutions in Hubei Province After Implementation of the Registration System
摘要
Abstract
Objective To investigate the current development status of drug clinical trial institutions in Hubei Province after the implementation of the registration system of drug clinical trial institutions.Methods Based on the announcement of qualification certification inspection for drug clinical trial institutions,and data of The Drug Clinical Trial Registry and Publicity Platform and The Drug Clinical trial Registry and Information Disclosure Platform,the qualification certification and registry status of drug clinical trial institutions in Hubei Province from February 1,2004 to September 30,2024,and the acceptance of trial projects from October 1,2021 to September 30,2024 were collected.The development status(such as number of registrations,geographical distribution,registration disciplines,principal investigators,number of trial projects undertaken,trial types,drug types,and supervision and inspection results)of each drug clinical trial institutions in Hubei Province was comprehensively analyzed.Results After the implementation of the drug clinical trial institution registration system,the number of drug clinical trial institutions in Hubei Province showed a significant growth trend.As of September 30,2024,a total of 64 institutions had completed the registration.Among 17 cities/prefectures/districts(including forest areas)in Hubei Province,except for Qianjiang City,Tianmen City,and Shennongjia Forest Area,the other 14 cities/prefectures/districts had drug clinical trial institutions,mainly concentrated in Wuhan City(60.94％).A total of 171 majors(including 132 majors related to Western Medicine,31 majors related to Traditional Chinese Medicine,and eight other majors)and 1 564 principal investigators registered,and the top three institutions in terms of the number of principal investigators were the Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology,Union Medical College Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology,and Wuhan University People's Hospital.The registered institutions have undertaken 5 901 drug clinical trial projects,of which the Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology and Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology have undertaken over 1 000 projects,accounting for 40.53％.The supervision and inspection results showed that some institutions still had deficiencies in organizational management,responsibility awareness,and quality system construction.Conclusion The implementation of the registration system for drug clinical trial institutions has effectively promoted the release and utilization of drug clinical trial resources in Hubei Province.However,it also highlights issues such as uneven regional development,insufficient leadership in advantageous disciplines,and weak core competitiveness.It is recommended to fully tap into and leverage the unique advantages of medical resources in Hubei Province,strengthen the construction of the quality system,improve service quality and efficiency,and promote the healthy and sustainable development of drug clinical trial institutions in Hubei Province.关键词
药物临床试验机构/备案制/湖北省/现状分析/存在问题Key words
drug clinical trial institutions/registration system/Hubei Province/current status analysis/existing problems分类
医药卫生引用本文复制引用
李天恩,许芳,汤安邦,王肇聪,魏学燕,胡喆,梁新军,张峰..湖北省药物临床试验机构备案制实施后发展现状分析[J].中国药业,2026,35(7):23-28,6.基金项目
湖北省武汉市科技局知识创新专项项目[2023020201020520]. （）
