Keene Oliver N
GlaxoSmithKline Research and Development, Stockley Park, Middlesex, UK.
Pharm Stat. 2011 May-Jun;10(3):191-5. doi: 10.1002/pst.421. Epub 2010 Mar 2.
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.
意向性分析（ITT）被视为能提供最小偏差的临床试验分析方法，但也可能出现一些棘手的问题。常见的分析方法，如混合效应模型和比例风险模型，通常被标记为ITT分析，但在实际应用中，它们往往与ITT原则的严格解释不一致。在那些退出治疗的患者可以获得有效药物的试验中，ITT分析可能会掩盖试验中所研究干预措施的重要治疗效果。治疗中数据的分析可能存在偏差，但在仔细审查各治疗组的退出模式，尤其是对于那些因缺乏疗效和不良事件而退出的患者时，它可以实现疗效目标。
