传染病防治药物临床试验信息管理平台的构建

摘要

目的 按照药物临床试验质量管理规范(good clinical practice,GCP)标准,建立传染病防治药物临床试验信息管理平台.方法 按照GCP 的临床试验规则,采用J2EE 技术、Struts 和Hibernate 的三层体系架构及数据库技术,构建传染病防治药物临床信息管理平台.结果 建立了包括电子数据采集系统、临床试验数据系统、GCP 项目管理系统和中央随机化管理系统在内的传染病药物临床信息管理平台.结论 使用传染病防治药物临床信息管理平台,显著增强了临床试验质量控制,为建立符合国际规范的传染病防治药物评价体系,准确评价药物的疗效和安全性奠定了基础.%Objective To establish standardized Infectious Diseases Drug Clinical Trial Information Management Platform according to the standards of good clinical practice (GCP). Methods The platform was established by using J2EE, Struts and Hibernate technique and database technology according to the clinical trial rules of GCP. Results The Infectious Diseases Drug Clinical Trial Information Management Platform, including electronic data collection system, clinical trial data management system, GCP project management system and interactive web response system, was developed successfully. Conclusions The Infectious Diseases Drug Clinical Trial Information Management Platform significantly improves the quality control of infectious diseases drug clinical trials. It has laid a foundation for the development of infectious diseases drug evaluation system, which conforms to the international standards and aims at assessing the efficacy and safety of the drugs for infectious diseases.