估计目标结构性框架及其在中药临床研究中的应用  

Framework of estimands and its application in clinical trials of traditional Chinese medicine

作　　者：蔡秋晗 胡思源[1] 钟成梁[1] 郭圣璇 CAI Qiuhan;HU Siyuan;ZHONG Chengliang;GUO Shengxuan(Clinical Trial Center,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)

机构地区：[1]天津中医药大学第一附属医院,国家中医针灸临床医学研究中心临床试验中心,天津300381

出　　处：《天津中医药》2022年第10期1289-1294,共6页Tianjin Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项——重大新药创制项目(2020 X09210-008)。

摘　　要：国际人用药品注册技术协调会(ICH)发布的E9(R1)文件,引入了估计目标的概念,用以更精准描述治疗效应,是建立试验目的、设计、实施、分析与解释间紧密逻辑关系的实用工具。文章从估计目标及其结构性框架、中药临床试验常见的伴发事件及处理策略、敏感性分析和补充分析、引入估计目标的临床试验方案设计等方面,对估计目标和敏感性分析及其在中药临床试验设计中的应用进行了探讨,供同道参考。ICH E9(R1)proposed a new concept of estimands to describe treatment effects more accurately,which is a practical tool to establish a close logical relationship among trial purpose,design,implementation,analysis and interpretation.In this paper,the application of estimands framework in the design of traditional Chinese medicine clinical trials were discussed from the aspects of the framework,the common intercurrent events and its treatment strategy in trials of traditional Chinese medicine,sensitivity and supplementary analysis,protocol with estimands.

关 键 词：E9(R1) 估计目标 中药临床研究 应用 

分 类 号：R24[医药卫生—中医临床基础]