药物临床试验不良反应因果关系评价方法概述与存在问题的思考

Overview of causality evaluation methods for adverse reactions in drug clinical trials and consideration of existing problems

目前,国际上对于临床试验期间的药物不良反应因果关系评价方法尚无统一标准,在实际工作中存在诸多问题与挑战。本文通过检索国内外文献,介绍了5种国内外较常用的因果关系评价方法和我国上市后药物不良反应因果关系判断法,对当前临床试验期间药物不良反应因果关系判定存在问题进行分析及探讨。

At present,there is no unified international standard for the causality assessment method of adverse reactions during clinical trials,and there are many problems and challenges in practical work.Through searching domestic and foreign literature,this paper introduced 5 commonly used methods of causality assessment at home and abroad and the judgment method of causality of adverse reactions after marketing in China,analyzed and discussed the existing problems in the determination of causality of adverse reactions during current clinical trials.