中国药物临床试验安全性信息监测和报告体系分析

发布时间：2018-05-28 13:49

本文选题：临床试验 + 安全　；参考：《中国新药与临床杂志》2015年01期

【摘要】：通过分析和解读药物临床试验不同参与方在安全性信息收集与处理中各自所扮演的角色和职责,将我国与欧美国家的药物临床试验安全性信息监测及报告体系进行比较,分析中国在此方面的特点与不足,为我国在加强和完善药物临床试验安全性信息监测和报告体系方面提出建议与期望。
[Abstract]:By analyzing and interpreting the roles and responsibilities of different participants in drug clinical trials in the collection and processing of safety information, the monitoring and reporting systems of safety information in clinical trials in China and in Europe and the United States were compared. This paper analyzes the characteristics and shortcomings of China in this field, and puts forward some suggestions and expectations for strengthening and perfecting the safety information monitoring and reporting system of drug clinical trials in China.
【作者单位】：国家食品药品监督管理总局高级研修学院;
【分类号】：R951

【参考文献】