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盲态审核是临床研究统计分析前的关键环节。本文以一项中药治疗急性气管-支气管炎新药Ⅲ期临床试验为例,从随机执行、盲法实施、未完成试验、纳入标准、排除标准、超窗情况、依从性、不良事件、合并用药、异常实验室数据等方面进行盲态审核。讨论不同偏离方案情况下如何进行数据集的划分,分析盲态审核中应注意的问题,并对规范临床研究盲态审核提出了建议性意见。
Blind review is the key link before statistical analysis of clinical research. This article takes a Chinese medicine treatment of acute bronchitis - bronchitis phase III clinical trials as an example, from random execution, blind implementation, unfinished trials, inclusion criteria, excluding standards, window conditions, compliance, adverse events, Abnormal laboratory data and other aspects of blind review. Discusses how to divide the dataset under different scenarios, analyzes the problems that should be noticed in the blind review, and puts forward some suggestions on the blind review of the standard clinical research.