Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials

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Abstract
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.1-7 This report outlines the challenges associated with conducting and reporting subgroup analyses, and it sets forth guidelines for their use in the Journal. Although this report focuses on the reporting of clinical trials, many of the issues discussed also apply to observational studies.