远程监查在临床试验中的应用与发展趋势  

The Application and Development Trend of Remote Monitoring in Clinical Trials

作　　者：陈欢[1] 陆益超 郭雨娇 张梦雨 殷奇印 何玲[1] 钟俊 郑莉[1] CHEN Huan;LU Yichao;GUO Yujiao;ZHANG Mengyu;YIN Qiyin;HE Ling;ZHONG Jun;ZHENG Li(West China Hospital of Sichuan University,Sichuan Chengdu 610041,China;New Trials Medical Technology(Hangzhou)Co.,Ltd.,Zhejiang Hangzhou 310000,China)

机构地区：[1]四川大学华西医院,四川成都610041 [2]新视焰医疗科技(杭州)有限公司,浙江杭州310000

出　　处：《中国医药导刊》2025年第2期212-216,共5页Chinese Journal of Medicinal Guide

基　　金：中国药品监督管理研究会,中国DCT监管策略与实践研究课题(2024-Y-Y-007)。

摘　　要：降本增效是提高临床试验研发投入回报率的重要课题。远程监查通过远程访问原始记录,可提高监查效率,降低运营成本。远程监查在临床试验领域的应用正逐渐改变传统临床试验模式。本研究通过分析国内外包括Sitelink远程监查平台在内的国内外远程监查实践案例,探讨了远程监查在临床试验中的应用现状、主要效益及面临的挑战。临床试验远程监查在我国尽管起步较晚,但发展迅速,已在多个研究中心成功实施,显示出巨大的潜力和价值。研究发现,远程监查能够显著提升数据可靠性,并优化资源分配。尽管远程监查目前仍面临数据完整性、研究中心指引不明确等挑战,但通过技术优化、法规与伦理指导、人员培训、数据安全与隐私保护等措施进行有效应对。远程监查系统的普及与推广,有望实现资源的最优分配和利用,提高临床试验的整体效率和数据的准确性,提升临床试验质量,为全球健康研究做出更大的贡献。Reducing costs and increasing efficiency is an important topic to improve the return on investment in clinical trial research and development.Remote monitoring improves audit efficiency and reduces operating costs by remotely accessing original records.The use of remote monitoring in clinical trials is changing the traditional clinical trial model.This study analyzes the practice cases of remote monitoring in clinical trials at home and abroad such as Sitelink remote monitoring platform,and discusses the application status,main benefits and challenges of remote monitoring in clinical trials.Although the remote monitoring of clinical trials started late in China,it is developing rapidly and has been successfully implemented in many research centers,showing great potential and value.The study found that remote monitoring can significantly improve data reliability and optimize resource allocation.Although remote monitoring faces chal-lenges such as data integrity and unclear site guidelines,these challenges can be effectively addressed through technical optimization,regulatory and ethical guidance,personnel training,data security and privacy protection,and other measures.The popularization and promotion of the remote monitoring system is expected to achieve the optimal allocation and utilization of resources,improve the overall efficiency and data accuracy of clinical trials,improve the quality of clinical trials,and make greater contributions to global health research.

关 键 词：远程监查 临床试验 数据完整性 数据安全 技术挑战 远程质控 

分 类 号：R95[医药卫生—药学]