本文選題：新藥 + 臨床試驗��； 參考：《中國新藥雜志》2017年18期

【摘要】：本文參考國內(nèi)外藥品注冊相關(guān)法規(guī)、技術(shù)要求和指導原則,根據(jù)20多年新藥審評經(jīng)驗和對技術(shù)標準及指導原則的深入理解,對新藥臨床試驗中療效指標概念和與療效指標選擇密切相關(guān)的幾種療效指標類型進行了分析和說明。對藥物臨床試驗中主要療效指標的特點以及主要療效指標和次要療效指標選擇的基本原則進行了梳理和歸納。對療效指標選擇時需要考慮的問題進行了詳細的概括和總結(jié)。對使用幾種常見類型療效指標進行療效評價時需要注意的事項和問題進行了認真的分析和討論。
[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.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評中心;
【分類號】：R95

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