期刊
PHARMACEUTICAL STATISTICS
卷 10, 期 3, 页码 191-195出版社
WILEY-BLACKWELL
DOI: 10.1002/pst.421
关键词
intent-to-treat; missing data; MMRM; per protocol; withdrawals
Intent-to-treat (ITT) analysis is viewed as the analysis of a clinical trial that provides the least bias, but difficult issues can arise. Common analysis methods such as mixed-effects and proportional hazards models are usually labeled as ITT analysis, but in practice they can often be inconsistent with a strict interpretation of the ITT principle. In trials where effective medications are available to patients withdrawing from treatment, ITT analysis can mask important therapeutic effects of the intervention studied in the trial. Analysis of on-treatment data may be subject to bias, but can address efficacy objectives when combined with careful review of the pattern of withdrawals across treatments particularly for those patients withdrawing due to lack of efficacy and adverse events. Copyright (C) 2010 John Wiley & Sons, Ltd.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据