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

姜敏; 林莉; 甘晨曦; 孙文雄; 许清松; 赵秀丽

doi:10.6039/j.issn.1001-0408.2025.03.03

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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

药事管理 | 更新时间：2025-02-10

- 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
- Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
- 中国药房 2025年36卷第3期页码：275-279
- 作者机构：
  
  1.江西省人民医院（南昌医学院第一附属医院）呼吸与危重症医学科，南昌;330006
  2.江西省人民医院（南昌医学院第一附属医院）临床试验与研究中心，南昌　330006
  3.江西省药品监督管理局药品注册管理处，南昌　330029
  4.南昌大学第一附属医院医学伦理委员会，南昌　330006
  5.首都医科大学附属北京同仁医院国家药物临床试验机构，北京　100730
- 作者简介：
  
  主任医师，硕士生导师，博士。研究方向：呼吸内科临床研究、临床试验管理。电话：0791-86895551。E-mail：jmjxnc@163.com
  教授，博士生导师。研究方向：临床药理、临床试验管理。电话：010-58268486。E-mail：lilyzhao1028@163.com
- 基金信息：
  
  江西省药品监督管理局科研项目(2021KY06)
- DOI：10.6039/j.issn.1001-0408.2025.03.03
  中图分类号： R95
- 纸质出版日期：2025-02-15，
  
  收稿日期：2024-08-16，
  
  修回日期：2024-12-15，
  
  录用日期：2024-12-16
- 稿件说明：
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姜敏,林莉,甘晨曦等.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[J].中国药房,2025,36(03):275-279.

JIANG Min,LIN Li,GAN Chenxi,et al.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system[J].ZHONGGUO YAOFANG,2025,36(03):275-279.
姜敏,林莉,甘晨曦等.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[J].中国药房,2025,36(03):275-279. DOI： 10.6039/j.issn.1001-0408.2025.03.03.

JIANG Min,LIN Li,GAN Chenxi,et al.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system[J].ZHONGGUO YAOFANG,2025,36(03):275-279. DOI： 10.6039/j.issn.1001-0408.2025.03.03.

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.

关键词

药物临床试验机构备案制管理状况项目承接

Keywords

filing systemmanagement statusproject undertaking

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