摘要
源数据管理是临床试验质量的核心环节,本研究结合电子源数据技术和电子数据采集系统(EDC),将人工智能技术(AI)集成于临床试验数据管理流程,自主研发了一套临床试验管理系统,旨在提高试验效率和质量。系统功能涵盖智能数据录入、智能质控、远程监查以及受试者智能筛选与招募。在一项鼻咽癌项目中的模拟应用表明,该系统大幅缩短了数据处理时间,提高了数据准确率,减少了现场监查次数,并加速了潜在受试者匹配。研究证明,AI技术对于临床试验质量控制至关重要,其进一步的开发与应用价值显著。
Source data management constitutes the cornerstone of clinical trial quality.By integrating electronic source data technology with Electronic Data Capture(EDC)systems,this study pioneers the incorporation of artificial intelligence(AI)into clinical trial data management and has developed a novel clinical trial management system aimed at enhancing trial efficiency and quality.The system incorporates intelligent data entry,automated quality control,remote monitoring capabilities,and automated subject screening and recruitment functions.A pilot application within a nasopharyngeal carcinoma study demonstrated significant improvements:markedly reduced data processing time,high data accuracy,decreased frequency of on-site monitoring visits,and accelerated patient matching.These findings underscore the key contribution of AI technology to clinical trial quality control and highlight its substantial potential for further refinement and practical implementation.
作者
赵仕杰
王婷
郑靖
王铮
解萌
梁婧
余杭
张旭东
ZHAO Shi-jie;WANG Ting;ZHENG Jing;WANG Zheng;XIE Meng;LIANG Jing;YU Hang;ZHANG Xu-dong(Department of Clinical Research,Sichuan Clinical Research Center for Cancer,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,University of Electronic Science and Technology of China,Chengdu 610041,China;Hangzhou Purui Life Technology Co.,Ltd.,Hangzhou 310000,China)
出处
《中国新药杂志》
北大核心
2026年第1期11-16,共6页
Chinese Journal of New Drugs
基金
四川省卫生健康委员会科技项目(23LCYJ054)。
关键词
临床试验
智能化
质量管理
clinical trials
intelligentization
quality control
