Analysis on the Construction and Development Status of Drug Clinical Trial Institutions in Jiangxi Province
10.3870/j.issn.1004-0781.2025.05.026
- VernacularTitle:江西省药物临床试验机构建设和管理调查分析
- Author:
Xiaohua CHENG
1
;
Li LIN
;
Huiting ZHU
Author Information
1. 南昌大学第一附属医院临床试验中心,南昌 330006
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Institution registration system;
Drug clinical trial institutions;
Operation and management
- From:
Herald of Medicine
2025;44(5):829-833
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate and analyze the construction and management status of drug clinical trial institu-tions in Jiangxi Province,and to provide a reference for institutions' standardized management and development.Methods The registered drug clinical trial institutions in Jiangxi Province were selected as the research objects in the"Drug and Medical De-vice Clinical Trial Institution Filing Management Information System",and the public data were retrieved.Questionnaires were sent to the registered medical institutions as"Questionnaire Star"to collect the questionnaire data.The data on the construction and management of drug clinical trial institutions were analyzed descriptively from multiple dimensions.Results By December 2023,52 drug clinical trial institutions and one vaccine clinical trial institution had been registered in Jiangxi Province.The organ-ization and management structure,personnel composition,hardware,and software of the registration institutions met the basic re-quirements for conducting drug clinical trials.In recent years,the number of drug clinical trial record institutions and the number of projects to undertake has increased year by year,and the management ability and comprehensive strength of clinical trial institu-tions have been continuously enhanced,and there is still a big gap compared with the developed areas of the pharmaceutical in-dustry.Conclusion There is unbalanced regional development,uneven ability of different institutions to undertake projects,a low level of clinical trial information management,and the comprehensive ability of clinical trials needs to be improved in Jiangxi Province.
