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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。
The safety evaluation of clinical trials relies heavily on in-depth and detailed analysis of adverse events. However, in practice, due to the different geographical regions, languages, nationalities and cultures, there are differences in expression of the same adverse events and difficulties in collecting and classifying data of adverse events, data management and statistical analysis. In order to ensure the essential attribution of the original intent of the adverse event, the problem of standardizing the terminology of adverse events must be addressed. The MedDRA (International Dictionary of Medical Terms) provides strong support for standardization of adverse events reporting in clinical trials and has been widely recommended and applied internationally. This article introduces the development, application scope, hierarchy, coding terminology selection and standard query strategy of Med DRA. On this basis, we further clarify the application procedure of Med DRA in the coding of adverse events in clinical trials and based on Med DRA coding The issue of statistical analysis of adverse events for a framework discussion.