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备案制实施后江西省药物临床试验机构管理现状及项目承接情况分析
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| 篇名： | 备案制实施后江西省药物临床试验机构管理现状及项目承接情况分析 |
| TITLE： | Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system |
| 摘要： | 目的 调研并分析备案制实施后江西省药物临床试验机构管理现状及项目承接情况。方法以江西省内已完成药物临床试验机构资质备案1年以上的新机构（在备案制实施期间获得资质）、老机构（在认定制实施期间获得资质）共38家为调查对象，对机构基本情况、备案的专业数量和主要研究者（PI）数量、组织管理机构硬件和信息化建设情况、人员配置及培训情况、机构承接药物注册临床试验数量等方面开展调研。结果38家被调研机构中，综合医院22家、专科医院16家；老机构24家，新机构14家。无论是综合医院还是专科医院，老机构核定床位数、门诊人数、住院人数、备案的专业数量和PI数量均多于新机构；新、老机构的机构办公室均具备独立的办公场所，新机构均设置了药物临床试验质量管理规范（GCP）药房；新机构使用临床研究管理系统的数量明显少于老机构；在综合医院层面，老机构中机构办公室专职管理员人数和机构办公室质量控制员人数明显多于新机构，而在专科医院层面则相反；新机构开展的培训数量要多于老机构；无论是综合医院还是专科医院，新机构承接药物注册临床试验项目数均明显少于老机构。结论新机构在医院综合实力和信息化方面比老机构差，承接临床试验项目数量不如老机构多。 |
| ABSTRACT： | OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions （obtained qualifications during the implementation of the filing system） and old institutions （obtained qualifications during the implementation of the recognition system） that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions， the number of registered principal investigator （PI）， institutional hardware and information construction， personnel allocation and training， and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed， there were 22 general hospitals and 16 specialized hospitals； there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals， the old institutions were better than the new institutions in the number of approved beds， the number of outpatients， the number of inpatients， the number of specialties， and the number of PI； both old and new institutions had separate offices； all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital， both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions， while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP， new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals， the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals， and the number of clinical trials undertaken by new institutions is also less than old institutions. |
| 期刊： | 2025年第36卷第03期 |
| 作者： | 姜敏；林莉；甘晨曦；孙文雄；许清松；赵秀丽 |
| AUTHORS： | JIANG Min，LIN Li，GAN Chenxi，SUN Wenxiong，XU Qingsong，ZHAO Xiuli |
| 关键字： | 药物临床试验机构；备案制；管理状况；项目承接 |
| KEYWORDS： | drug clinical trial institution； filing system； management status； project undertaking |
| 阅读数： | 3 次 |
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