药物临床试验期间药物安全监控体系的中外比较分析

International comparison of the monitoring systems of drug safety in clinical trials

比较了国内外临床试验中不良事件监控体系的区别。国内报告内容为严重不良事件,报告主体为研究者,报告时限为24 h,与药物的关联程度分级5级,报告形式为严重事件报告表。ICH相应内容为:报告内容为药物不良反应.报告主体为申办者,报告时限根据不良反应的类型分为7 d和15 d。多采用的CIOMS-I的表格形式。我国目前还存在重视不足、少报漏报等情况,需要建立建全临床试验期间完善的安全监控机制以及试验药物评价机构和系统。

The differences in monitoring systems for drug adverse event between China and other countries in clinical trials were analyzed. In China, the investigators are responsible to report severe adverse event （SAE） within 24 h. The assessment of relation between events and drug reaction is graded at 5 levels, and should be reported in the format of a severe adverse event form. By the requirement of ICH, adverse drug reaction should be reported by the sponsor within 7 or 15 days. A CIOMS-I form is commonly used for reporting. Currently, insufficient attention has been paid to the report of drug adverse events in clinical trials. Thus, the system of safety monitoring in China should be improved, and a better system of safety monitoring as well as the system of drug effect assessment should be established.