基于eTrial系统的Ⅰ期/生物等效性药物临床试验信息化管理平台建设  

Construction of Information Management Platform for PhaseⅠ/Bioequivalency Drug Clinical Trial Based on eTrial System

作　　者：陈倩[1] 任秀华[1] 王开富[1] 罗攀 刘东[1] 杜艾桦 CHEN Qian;REN Xiuhua;WANG Kaifu;LUO Pan;LIU Dong;DU Aihua(Phase I Clinical Unit,Department of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Office of Academic Research,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部Ⅰ期临床试验研究室,武汉430030 [2]华中科技大学同济医学院附属同济医院科研处,武汉430030

出　　处：《医药导报》2022年第5期729-732,共4页Herald of Medicine

基　　金：国家科技重大专项课题-重大新药创制(2017ZX09304022)。

摘　　要：目的研究信息化系统在Ⅰ期/生物等效性(BE)药物临床试验的建立及应用技术,确保高效率、高质量地开展药物临床试验。方法引进国内Ⅰ期临床试验信息化管理系统eTrial,根据华中科技大学同济医学院附属同济医院Ⅰ期临床试验的需求和实践经验对eTrial系统进行功能改造,结合医院已有信息系统,打造Ⅰ期临床研究的全流程信息化管理平台;采用该信息化平台对该院Ⅰ期临床在研项目进行全面信息化配置并全流程应用。结果通过系统培训、模拟配置和模拟演练,所有研究人员均熟练掌握系统的操作要点,建立起一整套符合该院Ⅰ期临床试验需求的电子化标准操作规程(eTrial SOP),并将该信息化平台实际应用于在研项目的管理和操作。结论通过信息化平台的建设和应用,促进Ⅰ期临床试验的流程规范化,提高了试验的管理效率,保证了试验结果的真实性和准确性,提升了药物临床试验管理水平和研究质量。Objective To establish and investigate the application technology of electronic information system for phaseⅠ/bioequivalency(BE)clinical trials(eTrial)in order to promote the efficiency and quality of clinical trials.Methods The electronic information management system for clinical trial was introduced to phaseⅠ/BE clinical trials in Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology.Stuff trainings and simulating exercises were organized.The system was optimized to meet with the requirements and practical experiences of phase I clinical trial site to achieve the best working condition.The eTrial system was configured and applied to the whole process of the research projects in our site.Results All of the researchers acquired the key points of system by systematically training,repeated practice and simulation.A set of electronic trial standard operating procedures(eTrial SOP)was set up to meet the requirements of our phase I clinical trial site.The system had been applied to the management and operation of the projects under research.Conclusion Introduction of the eTrial information system promoted the standardization of the whole process of the trials,improved the management efficiency of the test and ensured the authenticity and accuracy of the trial results.It plays an essential role in improving the management and research quality of clinical trials.

关 键 词：临床试验 电子信息化 数据溯源 

分 类 号：R95[医药卫生—药学]