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Special Report
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Volume 357:2189-2194 November 22, 2007 Number 21
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Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials
Rui Wang, M.S., Stephen W. Lagakos, Ph.D., James H. Ware, Ph.D., David J. Hunter, M.B., B.S., and Jeffrey M. Drazen, M.D.

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Medical research relies on clinical trials to assess therapeutic benefits. Because of the effort and cost involved in these studies, investigators frequently use analyses of subgroups of study participants to extract as much information as possible. Such analyses, which assess the heterogeneity of treatment effects in subgroups of patients, may provide useful information for the care of patients and for future research. However, subgroup analyses also introduce analytic challenges and can lead to overstated and misleading results.1,2,3,4,5,6,7 This report outlines the challenges associated with conducting and reporting subgroup analyses, and it sets forth guidelines for their use in the Journal. . . [Full Text of this Article]

Subgroup Analyses and Related Concepts

Subgroup Analysis

Heterogeneity and Statistical Interactions

Multiplicity

Prespecified Analysis versus Post Hoc Analysis

Subgroup Analyses in the Journal — Assessment of Reporting Practices

Analysis of Our Findings and Guidelines for Reporting Subgroups

Guidelines for Reporting Subgroup Analysis.


Related Letters:

Subgroup Analyses in Clinical Trials
Proestel S., Kent D., Hayward R., Wang R., Lagakos S. W., Drazen J. M.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1199-1200, Mar 13, 2008. Correspondence

More on Subgroup Analyses in Clinical Trials
Pocock S. J., Lubsen J., Wang R., Lagakos S. W.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:2076-2077, May 8, 2008. Correspondence

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