传染病防治药物临床试验管理系统的建立

Establishment of Infectious Diseases Drug Clinical Trial Management System

目的 建立具有自主知识产权的传染病防治药物临床试验管理系统,为传染病防治药物的研发提供技术保障。方法 本系统严格按照药品临床试验管理规范要求的业务流程和标准,基于J2EE开发平台,使用了BioKnow-UAP框架体系,运用Struts、Hibernate等架构技术和Oracle数据库存储数据。结果 本系统建立了标准化的临床试验评价手段和体系,并构建了严密的质量控制体系,保证临床评价数据管理的可靠性,健全了高效的人员培训体系,使药物临床研究更加符合人体生物医学研究伦理学要求,能够承担传染病防治药物的Ⅰ-Ⅳ期临床试验研究。结论 本系统成功构建了符合药品临床试验管理规范及适于传染病防治药物研究的临床试验评价体系,具有较高的实用价值。

Objective To establish Infectious Diseases Drug Clinical Trial Management System with self-owned intellectual property rights, so as to provide technical support for the research and development of drugs for infectious diseases. Methods Ac- cording to the procedure and standards of good clinical practice （GCP）, the system was constructed based on J2EE platform, Bin- Know Universal Application Platform, Struts and Hibernate technique and Oracle database. Results In the Infectious Diseases Drug Clinical Trial Management System, an effective evaluation system for infectious diseases drug clinical trims and a quality control system were established to guarantee the reliability of the management of clinical evaluation data, and an efficient personnel training system was improved to make the clinical research for infectious diseases meet the requirements of the ethics of biomedical research. The clinical trial management system could undertake the responsibility of carrying out phase I-1V clinical trials of drugs for infec- tious diseases. Conclusions Infectious Diseases Drug Clinical Trial Management System has established successfully. Conforming to GCP standards, it provides a good platform for the evaluation of clinical trails of drugs for infectious diseases, with high practical value.