MedDRA及其在不良事件分析中的应用

Med DRA and its applications in statistical analysis of adverse events

临床试验的安全性评价很大程度上依赖于对不良事件的深入细致分析。然而,实践中因受试者地域、语言、民族、文化等不同,存在着对同样的不良事件表达上的各异,给不良事件资料的汇总归类、数据管理和统计分析带来困难。为了确保不良事件原意表达的本质归属,必须解决不良事件术语标准化的问题。国际医学用语词典(Med DRA)可为临床试验不良事件报告标准化提供有力支持,已在国际上得到广泛推荐和应用。本文对Med DRA的发展情况、适用范围、层次结构、编码术语选择、标准查询策略等进行介绍,在此基础上,进一步阐明Med DRA在临床试验不良事件编码中的应用流程,并基于Med DRA编码对不良事件统计分析的相关事项进行框架性探讨。

Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse eventsto a great extent. However, there are difficulties in summary classification, data management and statisticalanalysis of the adverse events because of the different expressions on the same adverse events caused by regional,linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it＇s necessary tostandardize the terms in recording the adverse events. MedDRA （medical dictionary for regulatory activities）has been widely recommended and applied in the world as a powerful support for the adverse events reportingin clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding termselection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process ofadverse events encoding with MedDRA is proposed.events is discussed.Finally, the framework of statistical analysis about adverse