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Volume 358:1199-1200 March 13, 2008 Number 11
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Subgroup Analyses in Clinical Trials

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 by Wang, R.
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To the Editor: Wang et al. (Nov. 22 issue)1 provide a well-reasoned assessment of the statistical issues related to subgroup analyses. However, one important point that should be made is that significance testing during subgroup analyses is seldom appropriate. The majority of subgroup analyses are exploratory in nature, and no significance testing should be performed unless an alpha level needed to achieve significance is attributed to the comparison of interest in advance. Therefore, although a P value may appropriately be calculated to assess the degree of imbalance during such exploratory analyses, no subsequent significance testing should be allowed. On the . . . [Full Text of this Article]




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