摘要
目的:研究我国儿科人群药物临床试验开展情况,分析临床试验机构合作趋势与特征,为我国儿科人群药物临床试验协作网建设提供参考。方法:基于2013—2022年在国家药品监督管理局药品审评中心“药物临床试验登记与信息公示平台”公示的儿科人群药物临床试验项目数据,使用计量分析法和社会网络分析法进行研究特征与合作趋势分析。结果:640项公示项目中,多中心药物临床研究占87.50%(560项);抗肿瘤药及免疫调节剂、血液和造血系统用药是儿童药研发的热门类别;拥有优质临床试验资源的核心机构和核心主要研究者相对集中。结论:我国儿科人群药物临床试验项目逐年增长,部分机构间合作频繁,整体合作网络密度松散,有待进一步加强合作。
OBJECTIVE:To research the development of clinical trials in the pediatric population in China,analyze the trend and characteristics of cooperation among clinical trial institutions,so as to provide reference for constructing pediatric clinical medical research system.METHODS:Based on clinical trial research data of pediatric population published on the platform for registry and publicity of drug clinical trials by the Center for Drug Evaluation of National Medical Products Administration from 2013 to 2022,characteristics and cooperation trends were analyzed by using quantitative analysis and social network analysis methods.RESULTS:Among the 640 publicized projects,multi-center clinical research of drugs accounted for 87.50%(560 projects).Anti-tumor drugs and immunomodulators,blood and hematopoietic system drugs were popular categories in children’s drug research and development.Core institutions and core principal investigator with high-quality clinical trial resources were relatively concentrated.CONCLUSIONS:Clinical trial research of drugs in the pediatric population in China are increasing,with frequent cooperation among some institutions and a loose cooperation network density,which requires further strengthening of cooperation.
作者
王谦
丁倩
郭春彦
张怡
梁宇光
WANG Qian;DING Qian;GUO Chunyan;ZHANG Yi;LIANG Yuguang(National Center for Children’s Health/Clinical Research Center,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)
出处
《中国医院用药评价与分析》
2024年第3期257-260,264,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
北京市研究型病房建设示范单位项目(No.BCRW202101)
北京市卫生健康委员会北京市卫生健康科技成果和适宜技术推广项目(No.BHTPP2022066)
首都医科大学附属北京儿童医院管理课题项目(No.YGLY2022001)。
关键词
儿科人群
多中心药物临床试验
社会网络分析
Pediatric population
Multi-center clinical trial of drugs
Social network analysis
