Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials

Key Points

• Examine the methodological strengths and limitations of subgroup analyses in clinical trials while presenting journal reporting standards.
• Evaluated methodological principles and statistical pitfalls associated with subgroup analyses across clinical trial data sets.
• Outlined updated journal publication policies governing the reporting and interpretation of subgroup findings.
• Identified critical risks of false-positive findings and misleading conclusions arising from unplanned or inadequately powered subgroup evaluations.
• Established reporting criteria to ensure subgroup claims are appropriately pre-specified, statistically contextualized, and cautiously interpreted.