药物临床试验中疗效指标的选择

发布时间：2018-04-22 21:39

本文选题：新药 + 临床试验　；参考：《中国新药杂志》2017年18期

【摘要】：本文参考国内外药品注册相关法规、技术要求和指导原则,根据20多年新药审评经验和对技术标准及指导原则的深入理解,对新药临床试验中疗效指标概念和与疗效指标选择密切相关的几种疗效指标类型进行了分析和说明。对药物临床试验中主要疗效指标的特点以及主要疗效指标和次要疗效指标选择的基本原则进行了梳理和归纳。对疗效指标选择时需要考虑的问题进行了详细的概括和总结。对使用几种常见类型疗效指标进行疗效评价时需要注意的事项和问题进行了认真的分析和讨论。
[Abstract]:This paper refers to the relevant regulations, technical requirements and guiding principles of drug registration at home and abroad, according to more than 20 years' experience of new drug review and in-depth understanding of technical standards and guiding principles. In this paper, the concept of efficacy index and several effective index types which are closely related to the selection of efficacy indexes in clinical trials of new drugs are analyzed and explained. The characteristics of the main efficacy indexes and the basic principles of the selection of the main curative effect indexes and the secondary curative effect indexes in the clinical trials of drugs were summarized and summarized in this paper. The problems that need to be considered in the selection of therapeutic indicators are summarized and summarized in detail. This paper analyzes and discusses the matters and problems that should be paid attention to in the evaluation of curative effect by using several common types of curative effect indexes.
【作者单位】：国家食品药品监督管理总局药品审评中心;
【分类号】：R95

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