基于医疗大数据的临床试验创新系统设计与实践

Design and Practice of Clinical Trial Innovation System Based on Medical Big Data

目的设计并建设基于医疗大数据的临床试验创新系统,为医院临床试验提质加速。方法基于我院现有的科研大数据平台和临床试验管理信息系统,结合新版GCP和有关文件精神,设计并建立了临床试验创新系统。结果建立了基于医疗大数据的临床试验创新系统,为临床试验全过程提供数据支撑和智能化管理,可实现临床试验项目管理、受试者管理和数据管理三个主要功能模块;经过初步实践应用,该系统能够切实提高临床试验效率和试验质量。结论临床试验创新系统能够有效提升临床试验效率和质量,保障受试者安全,降低研究成本,为我院开展基于大数据的智能创新临床试验创造了有利条件。

Objective To design and develop a clinical trial innovation system based on medical big data to improve the quality of clinical trials and accelerate the progress.Methods The clinical trial innovation system was designed and developed based on the existing big data platform of scientific research and clinical trial management system of our hospital and according to the new version of GCP and related documents.Results The clinical trial innovation system provided data support and intelligent management for the entire clinical trial process,and realized three main functional modules,including clinical trial project management,subject management and data management.After preliminary practice,the system could effectively improve the efficiency and quality of clinical trials in our hospital.Conclusion The clinical trial innovation system can effectively improve the efficiency and quality of clinical trials,ensure the safety of subjects,reduce research costs,creating favorable conditions for carrying out intelligent innovative clinical trials based on big data in our hospital.