湖北省药物临床试验机构备案制实施后发展现状分析OA
Current Development Status of Drug Clinical Trial Institutions in Hubei Province After Implementation of the Registration System
目的 探讨湖北省药物临床试验机构在药物临床试验机构备案制实施后的发展现状.方法 查询药物临床试验机构资格认定检查公告,检索药物临床试验机构备案管理信息系统、药物临床试验登记与信息公示平台的数据,收集湖北省药物临床试验机构2004 年 2 月 1 日至 2024 年 9 月 30 日的资格认定和备案情况,以及 2021 年 10 月 1 日至 2024 年 9 月 30 日承接试验项目情况.对湖北省各药物临床试验机构的发展现状(如备案数量、地域分布、备案专业、主要研究者、承接试验项目数量、试验类型、药物类型、监督检查结果)进行全面剖析.结果 药物临床试验机构备案制实施后,湖北省的药物临床试验机构数量呈显著增长趋势,截至 2024 年9 月 30 日,共有 64 家完成备案;湖北省共有 17 个市/州/区(含林区),除潜江市、天门市、神农架林区外,其余 14 个市/州/区均有药物临床试验机构分布,且主要集中分布在武汉市(60.94%);累计备案了171个专业,其中,西医相关专业132个,中医相关专业31个,其他专业 8 个;共有 1 564 名主要研究者,主要研究者数量排名前 3 的机构分别为华中科技大学同济医学院附属同济医院、华中科技大学同济医学院附属协和医院、武汉大学人民医院;备案机构累计承接药物临床试验项目 5 901 项,其中华中科技大学同济医学院附属协和医院和华中科技大学同济医学院附属同济医院承接项目均超 1 000 项,共占 40.53%;监督检查结果显示,部分机构在组织管理、责任意识、质量体系建设等方面仍存在不足.结论 药物临床试验机构备案制的实施,有效促进了湖北省药物临床试验资源的释放与利用,但同时也凸显出了区域发展不均衡、优势学科引领力不足、核心竞争力薄弱等问题.建议充分挖掘并发挥湖北省医疗资源的独特优势,强化质量体系建设,提升服务质量和效率,推动湖北省药物临床试验机构健康、持续发展.
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.
李天恩;许芳;汤安邦;王肇聪;魏学燕;胡喆;梁新军;张峰
华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079上海妙一生物科技有限公司,上海 201101华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079华中科技大学同济医学院附属肿瘤医院·湖北省肿瘤医院药物临床试验机构,湖北 武汉 430079
医药卫生
药物临床试验机构备案制湖北省现状分析存在问题
drug clinical trial institutionsregistration systemHubei Provincecurrent status analysisexisting problems
《中国药业》 2026 (7)
23-28,6
湖北省武汉市科技局知识创新专项项目[2023020201020520].
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