Choice of the Reference Set in a Randomization Test Based on Linear Ranks in the Presence of Missing Values
Choice of the Reference Set in a Randomization Test Based on Linear Ranks in the Presence of Missing Values
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DOI：
10.1080/03610918.2012.625797
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发表时间：
2012-01-01
影响因子：
0.9
通讯作者：
Heussen, Nicole
中科院分区：
文献类型：
--
作者：
Kennes, Lieven Nils;Hilgers, Ralf-Dieter;Heussen, Nicole
尽管监管指南明确要求（ICH E8），但在临床试验的统计分析中，随机化程序和分析之间的联系经常被忽略。随机化检验符合这些要求，因为它们使用应用的随机分配来确定检验统计量的分布。然而，缺失值对随机化检验的影响到目前为止还没有研究。我们探讨了使用随机化测试时，分析数据的随机临床试验缺失值。我们将考虑两种情况，导致减少或非减少的参考集取决于处理缺失数据。在正态近似下研究随机化检验的p值，对于小样本量，进行精确随机化检验。
The connection between the randomization procedure and analysis is often ignored in the statistical analysis of clinical trials although regulatory guidelines explicitly call upon (ICH E8). Randomization tests comply with these requirements, as they use the applied random allocation to determine the distribution of the test statistic. However, the impact of missing values on randomization tests is not studied up to now. We explore the use of a randomization test when analyzing data of randomized clinical trials with missing values. We will consider two scenarios leading to a reduced or non-reduced reference set depending on handling missing data. Investigations of p-values of randomization tests under normal approximation and, for small sample sizes, exact randomization tests were conducted.