Missing data: Discussion points from the PSI missing data expert group
Missing data: Discussion points from the PSI missing data expert group
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DOI：
10.1002/pst.391
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发表时间：
2010-10-01
影响因子：
1.5
通讯作者：
Yu, Ly-Mee
中科院分区：
文献类型：
--
作者：
Burzykowski, Tomasz;Carpenter, James;Yu, Ly-Mee
2001年12月，健康和药品委员会（CHMP）通过了缺失数据的考虑要点文件。2007年9月，CHMP发布了一项审查该文件的建议，特别强调总结和批判性评价脱落模式，解释“末次观察值结转”方法的作用和局限性，并描述CHMP对使用混合模型的谨慎立场。为准备发布最新的指导文件，制药业统计人员于2008年9月举行了为期一天的专家组会议。讨论的主题包括最大限度地减少缺失数据的程度和理解缺失数据的机制，确定处理缺失数据的原则和理解不同分析方法的假设。会议发出的一个明确信息是，目前，生物统计学家往往只对缺失数据作出反应。在设计临床试验时，进行有限的主动规划。在计划阶段需要考虑试验的缺失数据机制，并评估对目标的影响。另一个需要改进的领域是理解试验期间观察到的缺失数据的模式，从而通过绘制数据来理解缺失数据的机制;例如，使用Kaplan-Meier曲线来观察退出时间。版权所有（C）2009约翰威利父子有限公司
The Points to Consider Document on Missing Data was adopted by the Committee of Health and Medicinal Products (CHMP) in December 2001. In September 2007 the CHMP issued a recommendation to review the document, with particular emphasis on summarizing and critically appraising the pattern of drop-outs, explaining the role and limitations of the 'last observation carried forward' method and describing the CHMP's cautionary stance on the use of mixed models. In preparation for the release of the updated guidance document, statisticians in the Pharmaceutical Industry held a one-day expert group meeting in September 2008. Topics that were debated included minimizing the extent of missing data and understanding the missing data mechanism, defining the principles for handling missing data and understanding the assumptions underlying different analysis methods.A clear message from the meeting was that at present, biostatisticians tend only to react to missing data. Limited pro-active planning is undertaken when designing clinical trials. Missing data mechanisms for a trial need to be considered during the planning phase and the impact on the objectives assessed. Another area for improvement is in the understanding of the pattern of missing data observed during a trial and thus the missing data mechanism via the plotting of data; for example, use of Kaplan-Meier curves looking at time to withdrawal. Copyright (C) 2009 John Wiley & Sons, Ltd.