我国西北地区临床试验机构信息化管理的探索与实践  

Exploration and practice of informatization of clinical trial institution management in Northwest China

作　　者：刘妤 张彩霞[1] 易秋月[1] 卫荣[1] 刘清悦 刘霞 张亚妮[1] 刘欣然 马现福 阎昭 陆明莹[1] LIU Yu;ZHANG Cai-xia;YI Qiu-yue;WEI Rong;LIU Qing-yue;LIU Xia;ZHANG Ya-ni;LIU Xin-ran;MA Xian-fu;YAN Zhao;LU Ming-ying(The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;Tianjin Abeisinu Technology Co.,Ltd.,Tianjin 300000,China;China Anti-Cancer Association,Tianjin 300384,China)

机构地区：[1]西安交通大学第一附属医院,西安710061 [2]天津阿贝斯努科技有限公司,天津300000 [3]中国抗癌协会,天津300384

出　　处：《中国新药杂志》2023年第4期404-409,共6页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目:西北地区恶性肿瘤新药临床评价示范性技术平台建设(2020ZX09201020)。

摘　　要：目的:依托先进的临床研究管理理念,采用信息化技术手段,改变我国西北地区临床试验机构条件与水平相对落后的局面,探索解决我国临床试验发展不均衡的问题。方法:结合西安交通大学第一附属医院临床试验机构日常工作需求和管理经验,开发建立符合新时期监管要求的临床试验机构管理信息化平台(clinical trial institution management system,CTIMS),并为西北地区临床试验机构的临床研究能力和管理水平的提升提供解决方案。结果:西北地区临床试验机构通过临床试验机构信息化平台,可获得规范化、数字化、智能化的临床试验管理方式,使其进入临床研究的“快车道”,达到缩小与沿海发达地区临床研究机构能力差距的目的。结论:通过临床试验机构管理系统的应用,提升西北地区临床试验机构临床研究能力和管理效率及水平,改善西北地区临床试验发展相对落后的局面。Objective:To improve the relatively backward condition and level of clinical trial institutions in Northwest China by relying on advanced clinical research management concepts and adopting information technology,and explore solutions for the uneven development of clinical trial institutions in China.Methods:Based on the daily work requirements and management experience of the clinical trial institution in the First Affiliated Hospital of Xi’an Jiaotong University,we developed the Clinical Trial Institution Management System(CTIMS)meeting the regulatory requirements in the new period and provided solutions for the improvement of research ability and management level of clinical trial institutions in Northwest China.Results:By using the CTIMS,the clinical trial institutions in Northwest China can obtain standardized,digital,and intelligent clinical trial management methods,so that they can enter the“fast lane”of clinical research and achieve the goal of narrowing the capacity gap with clinical trial institutions in developed areas.Conclusion:Through the application of the CTIMS,the clinical research capacity,management efficiency and level of clinical trial institutions,as well as the relatively backward situation of clinical trial development in Northwest China will be improved.

关 键 词：临床试验 信息化平台 西北地区 

分 类 号：R95[医药卫生—药学]