Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
- VernacularTitle: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
- Author:
Min JIANG
1
,
2
;
Li LIN
3
;
Chenxi GAN
2
;
Wenxiong SUN
4
;
Qingsong XU
2
;
Xiuli ZHAO
5
Author Information
1. Dept. of Respiratory and Critical Care Medicine，Jiangxi Provincial People’s Hospital （the First Affiliated Hospital of Nanchang Medical College），Nanchang 330006，China
2. Clinical Trial and Research Center，Jiangxi Provincial People’s Hospital （the First Affiliated Hospital of Nanchang Medical College），Nanchang 330006，China
3. Drug Registration Management Office，Jiangxi Provincial Drug Administration，Nanchang 330029，China
4. Medical Ethics Committee of the First Affiliated Hospital of Nanchang University，Nanchang 330006，China
5. National Clinical Trial Institution of Beijing Tongren Hospital，Capital Medical University，Beijing 100730，China
- Publication Type:Journal Article
- Keywords:
drug clinical trial institution;
filing system;
management status;
project undertaking
- From:
China Pharmacy
2025;36(3):275-279
- CountryChina
- Language:Chinese
-
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.
