医疗机构药物临床试验信息化管理系统建设进展  

Research advances of optimizing management information systems of drug clinical trials at medical institutions

作　　者：曹端文 李蒲[1] 黄世博 余路易 温金华[1] CAO Duanwen;LI Pu;HUANG Shibo;YU Luyi;WEN Jinhua(Clinical Trial Research Center,First Affiliated Hospital,Nanchang University,Jiangxi Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院GCP中心,江西南昌330006

出　　处：《中国医院药学杂志》2024年第17期2056-2061,共6页Chinese Journal of Hospital Pharmacy

基　　金：江西省科学技术厅国际科技合作项目(编号:20232BBH80007)。

摘　　要：随着国家持续深化医药卫生体制改革,近年来药物临床试验与临床试验机构的数量实现“双增长”,推动了药物临床试验信息化建设快速发展。该文归纳了医疗机构药物临床试验信息化建设阶段性成果,分析了药物临床试验管理系统在医疗机构管理中的作用,介绍了临床试验系统设计与构建的方法,综述了近年来药物临床试验信息化建设前沿技术的运用,思考了医疗机构药物临床试验信息化建设过程中一些待解决的问题并展望其前景,通过信息化赋能药物临床试验开展,提高医疗机构临床试验办公室的服务效率和临床试验整体数据质量,加快新药临床研究进程,促进医疗机构高质量发展。With continuously deepening reforms of medicine and healthcare system,the scale of drug clinical trials and clinical trial institutions has achieved"double growth"in recent years,promoting a rapid development of information construction of clinical trials.Here phased achievements of clinical trial informationization at medical institutions were summarized.Also discussed included the role of clinical trial management system in institutional management,methods of designing and implementing clinical trials,applications of cutting-edge technologies and outstanding problems and future perspectives of clinical trial informationization.Optimized informatization construction of clinical trial management may boost service efficiency and data quality of clinical trials and accelerate the evaluation processes of new drugs.

关 键 词：药物临床试验 临床试验机构 信息系统 临床试验管理 

分 类 号：R95[医药卫生—药学]