Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system

JIANG Min; LIN Li; GAN Chenxi; SUN Wenxiong; XU Qingsong; ZHAO Xiuli

doi:10.6039/j.issn.1001-0408.2025.03.03

您当前的位置：

首页 >

文章列表页 >

Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system

更新时间：2025-09-26

- Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
- ZHONGGUO YAOFANG Vol. 36, Issue 3, Pages: 275-279(2025)
- 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：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.03.03
  CLC： R95
- Received：16 August 2024，
  
  Revised：2024-12-15，
  
  Accepted：16 December 2024，
  
  Published：15 February 2025
- 稿件说明：
移动端阅览
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

Keywords

references

中共中央办公厅，国务院办公厅 . 关于深化审评审批制度改革鼓励药品医疗器械创新的意见 [EB/OL ] .[ 2024-06-08 ] . https：//www.gov.cn/gongbao/content/2017/content_5232362.htm https://www.gov.cn/gongbao/content/2017/content_5232362.htm .

The General Office of the CPC Central Committee ， The General Office of the State Council . Opinions on deepe- ning the reform of the review and approval system and encouraging the innovation of drugs and medical device [EB/OL ] .[ 2024-06-08 ] . https：//www.gov.cn/gongbao/content/2017/content_5232362.htm https://www.gov.cn/gongbao/content/2017/content_5232362.htm .

国家药品监督管理局，国家卫生健康委员会 . 药物临床试验机构管理规定 [EB/OL ] .[ 2024-06-08 ] . https：//www.gov.cn/gongbao/content/2020/content_5496785.htm https://www.gov.cn/gongbao/content/2020/content_5496785.htm .

National Medical Products Administration ， National Health Commission . Administrative regulations of drug clinical trial sites [EB/OL ] .[ 2024-06-08 ] . https：//www.gov.cn/gongbao/content/2020/content_5496785.htm https://www.gov.cn/gongbao/content/2020/content_5496785.htm .

唐仕炜，刘泽玉，谷娟，等 . 我国药物临床试验机构地域和专业分布现状与思考 [J ] . 中国药业， 2018 ， 27 （ 24 ）： 1 - 4 .

TANG S W ， LIU Z Y ， GU J ， et al . Current situation and thought of geographical and professional distribution of good clinical practice institutions in China [J ] . China Pharm ， 2018 ， 27 （ 24 ）： 1 - 4 .

尤玉芳，高菲菲，许璇，等 . 备案制后我国药物临床试验机构现状分析 [J ] . 中国新药与临床杂志， 2023 ， 42 （ 3 ）： 170 - 174 .

YOU Y F ， GAO F F ， XU X ， et al . Analysis on present situation of drug clinical trial institutions in China after implementation of registration system [J ] . Chin J New Drugs Clin Remedies ， 2023 ， 42 （ 3 ）： 170 - 174 .

杨雅莉，李娟 . 备案制后四川省药物临床试验机构现状分析 [J ] . 中国药事， 2021 ， 35 （ 9 ）： 988 - 993 .

YANG Y L ， LI J . Analysis on the present situation of drug clinical trial institutions in Sichuan Province after the registration system [J ] . Chin Pharm Aff ， 2021 ， 35 （ 9 ）： 988 - 993 .

王宏伟，李彩霞 . 内蒙古自治区药物临床试验机构备案现状分析与思考 [J ] . 北方药学， 2022 ， 19 （ 4 ）： 192 - 196 .

WANG H W ， LI C X . Analysis and reflection on the current situation of drug clinical trial institutions’s record-keeping of the Inner Mongolia [J ] . J N Pharm ， 2022 ， 19 （ 4 ）： 192 - 196 .

张娟利，刘美佑，樊婷婷，等 . 陕西省药物临床试验机构现状分析 [J ] . 中南药学， 2024 ， 22 （ 2 ）： 548 - 552 .

ZHANG J L ， LIU M Y ， FAN T T ， et al . Current situation of drug clinical trial institutions in Shaanxi province [J ] . Cent South Pharm ， 2024 ， 22 （ 2 ）： 548 - 552 .

王甜甜，杨芳芳，李思奇，等 . 备案制下贵州省药物临床试验机构发展现状分析 [J ] . 中国药事， 2024 ， 38 （ 7 ）： 763 - 767 .

WANG T T ， YANG F F ， LI S Q ， et al . Analysis on the current development state of drug clinical trial institutions in Guizhou Province under the registering system [J ] . Chin Pharm Aff ， 2024 ， 38 （ 7 ）： 763 - 767 .

林小倩，黄芳玲，郑铃 . 福建省药物临床试验机构备案现状分析 [J ] . 中国药事， 2024 ， 38 （ 5 ）： 558 - 566 .

LIN X Q ， HUANG F L ， ZHENG L . Analysis of the current registering situation of drug clinical trial institutions in Fujian province [J ] . Chin Pharm Aff ， 2024 ， 38 （ 5 ）： 558 - 566 .

张勋，邹燕琴，陈燕，等 . 广东省药物临床试验机构备案情况及监管现状分析 [J ] . 中国医药导刊， 2024 ， 26 （ 6 ）： 555 - 559 .

ZHANG X ， ZOU Y Q ， CHEN Y ， et al . Analysis on the fi- ling and supervising status of drug clinical trial institutions in Guangdong Province [J ] . Chin J Med Guide ， 2024 ， 26 （ 6 ）： 555 - 559 .

宁靖，吴昊，高荣 . 药物临床试验机构备案要求及常见问题分析 [J ] . 中国临床药理学杂志， 2021 ， 37 （ 1 ）： 3 - 7 .

NING J ， WU H ， GAO R . Requirements and common issues in the registration system for drug clinical trial institutions [J ] . Chin J Clin Pharmacol ， 2021 ， 37 （ 1 ）： 3 - 7 .

张莹莹，李晶，李明，等 . 机构备案制下临床试验工作开展的几点思考 [J ] . 中国新药杂志， 2022 ， 31 （ 6 ）： 586 - 589 .

ZHANG Y Y ， LI J ， LI M ， et al . Several thoughts on conduction of clinical trials under institution registration system [J ] . Chin J New Drugs ， 2022 ， 31 （ 6 ）： 586 - 589 .

崔慧霞，李海菊，宋岩珺，等 . 备案制下新的药物临床试验机构运行分析 [J ] . 中国药物与临床， 2020 ， 20 （ 22 ）： 3847 - 3849 .

CUI H X ， LI H J ， SONG Y J ， et al . Analysis on the operation of new drug clinical trial institutions under the filing system [J ] . Chin Remedies Clin ， 2020 ， 20 （ 22 ）： 3847 - 3849 .

Views

109

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

No data

Related Author

No data

Related Institution

No data

⁰