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临床研究信息化的发展及未来展望

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信息技术的高速发展,为各行各业带来了信息化、自动化和智能化的变革,执行效率不断提升,运营成本不断降低.在药物临床试验研究领域,各项新型药物临床试验技术也应运而生.但药物临床研究信息化的推进,需要药物递送系统及时性、护理人员上门随访等协同,目前信息化应用方面存在系统整合、人员使用、运营管理、执行成本、数据录入等新挑战.药物临床研究信息化发展现状已不能满足当前国际国内药物临床研究发展形势,药物临床试验电子化系统标准规范亟需与国际接轨,药物临床研究信息化技术应用亟待提升,以受试者为中心开展去中心化临床试验(DCT)发展模式亟需深入探索.药物临床试验中药物直达患者(DTP)、远程监查等正在成为热门话题.在符合相关法律法规要求的前提下,通过DCT相关方法,持续赋能药物临床试验临床研究高效实施成为未来新的方向和挑战.本研究在梳理临床研究信息化发展背景的基础上,概述其当前发展现状,重点介绍药物临床研究信息化的展开模式,旨在借助智能化临床试验管理平台及远程通讯技术,以受试者为中心开展临床试验.
The Development and Outlook of Clinical Trial Informationization
The development of IT(information technology)has brought the huge innovation for informationization,automation and intelligentization for entire industries,as a result,the operation efficiency is increased while the cost is going down.Numerous innovative clinical trial technology have come out.However,the advancement of information technology in drug clinical research requires collabora-tion such as timely drug delivery systems and on-site follow-up by nursing staff.At present,there are some new challenges in the applica-tion of IT,such as system integration,talent availability,operation management,execution cost,data entry etc.The traditional IT sys-tem has become unmatched with the current development of clinical trials.The standard of clinical trial information technology needs to be consistent with international standard.The IT application in drug clinical trials needs to be improved,and the decentralized clinical trial(DCT)model is yet to be explored.DCT,remote follow-up,DTP and remote monitoring have become hot topics recently.In compli-ance with regulatory requirements,with the assistance of DCT,the high efficiency of clinical trial operation will definitely become the new trend.This article reviews the current development of clinical trial electrohic system and introduces the models of clinical trial infor-mationization,in order to provide some basis for decentralized clinical trial with the assistance of intelligent clinical trial platform and remote communication technology.

Clinical trial informationizationElectronic systemDecentralized clinical trialFuture outlook

孔亮、孔维迈

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礼新医药科技(上海)有限公司, 上海 201203

蒙特维德学院,美国 佛罗里达州 34756

临床研究信息化 电子化系统 去中心化临床试验 未来展望

2024

中国医药导刊
国家食品药品监督管理局信息中心

中国医药导刊

影响因子:1.408
ISSN:1009-0959
年,卷(期):2024.26(2)
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