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Randomisation, controll and blinding are classic designs for drug clinical trials. This article introduced the classification and implementation of blinding, and the particularity of blinding in traditional Chinese medicine clinical trials. Then discussed some concerns about design and implementation of blinding in traditional Chinese medicine clinical trials, such as, should pay attention to the similarity evaluation of placebo, and should design the protocol and process based on the similarity of the placebo, and some problems about the blinding in the dose-finding trails and the packaging and label of investigational product.

, authors=Cai-mei SONG, authorsList=Cai-mei SONG, authorCompany=null, correspAuthors=Cai-mei SONG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291707029815586826, articleId=1291707029203218440, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=中药新药临床试验中盲法设计与实施的思考, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

随机、对照、盲法是经典的药物临床试验设计。本文首先介绍了盲法的分类及实施方法，以及中药临床试验中实施盲法的特殊性。然后，对中药临床试验中盲法设计和实施应注意的一些问题进行了探讨，如应重视安慰剂模拟效果的评价，应根据安慰剂模拟效果进行合理的方案和流程设计，剂量探索试验中盲法设计与实施的一些问题，以及试验药物的包装和标签应注意的问题。

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宋彩梅（1983-），女，助理研究员，主要从事中药民族药临床专业审评工作

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宋彩梅（1983-），女，助理研究员，主要从事中药民族药临床专业审评工作

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