Development status and thinking of drug clinical trials in northwest China: taking Shaanxi Province as an example
10.3760/cma.j.cn113565-20240830-00212
- VernacularTitle:西北地区药物临床试验发展现状与思考
- Author:
Jia JU
1
;
Qi ZHANG
;
Bin FENG
;
Hongxu YANG
;
Shuibing LIU
;
Huan ZHANG
;
Yihuan LIU
;
Tian ZHANG
;
Zhongying MA
Author Information
1. 口颌系统重建与再生全国重点实验室/国家口腔疾病临床医学研究中心/陕西省口腔生物工程技术研究中心，空军军医大学口腔医院药剂科，西安 710032
- Publication Type:Journal Article
- Keywords:
Registration system;
Shaanxi Province;
Drug clinical trials;
Development status
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):150-155
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To review drug clinical trial development in Shaanxi province and to understand the effectiveness of the implementation of a record system in promoting drug clinical trial development.Methods:Based on the data of drug clinical trials in Shaanxi province released on the official website of the National Medical Products Administration, this study made a statistical analysis of the number of drug clinical trial institutions, regional distribution, registered majors and principal investigators, and the development of drug clinical trial projects.Results:After implementing drug clinical trial institution registration, the drug clinical trial institutions in Shaanxi Province developed rapidly, increasing from 20 in the qualification period to 46, with a growth rate of 130%. A total of 113 specialties were recorded, of which the highest number of professional records were for endocrinology and oncology. 46 institutions recorded 1, 094 principal investigators and participated in 3803 drug clinical trial projects. However, only 8 institutions had undertaken drug clinical trial projects as group leaders.Conclusions:The number of drug clinical trial institutions in Shaanxi province increased significantly, reflecting a good overall development status. However, issues still exist, such as unbalanced development of clinical trial resources within the region, insufficient researchers with the ability to conduct clinical trials, relatively concentrated drug clinical trial projects, and lack of experience in undertaking clinical trials as a group leader.
