On the treatment effect in clinical trials with dropout.

On the treatment effect in clinical trials with dropout.
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关于退出临床试验的治疗效果。

DOI:
10.1080/10543400500406488
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发表时间:
2006
期刊:
Journal of biopharmaceutical statistics.
影响因子:
--
通讯作者:
Zhong,Bob
Zhong,Bob
中科院分区:
--
文献类型:
--
作者:
Shao,Jun;Zhong,Bob

文献摘要

相似文献

在多次计划访视的临床试验中,患者脱落的情况时有发生,这给不完整数据的分析带来了极大的挑战。作为第一步,必须定义相关的治疗效果参数,这在存在脱落的情况下并不简单。我们讨论并比较了在大多数临床数据分析中采用的两种不同的治疗效果参数:研究结束时的治疗效果和末次观察到的治疗效果。一些相关的问题,如因果参数的可估计性,辍学模式的研究参数的依赖性,以及使用末次观察结转,也进行了讨论。
Patient's dropout often occurs in clinical trials with multiple scheduled visits, which results in a great challenge in the analysis of incomplete data. As the first step, one has to define a relevant treatment effect parameter, which is not straightforward in the presence of dropout. We discuss and compare two different treatment effect parameters that are adopted in most analyses of clinical data: the study-end treatment effect and the last-observed treatment effect. Some related issues, such as the estimability of causal parameters, the dependence of study parameters on the dropout patterns, and the use of the last observation carry forward, are also discussed.