Sample size considerations to assess sex-related treatment effects
Authors' conclusion
Achieving representative participation and representative contribution to knowledge gained requires relatively small increases in sample size and is mainly driven by sex differences in disease rates. However, sample size requirements for RCTs powered to assess sex differences in treatment effects are unfeasibly large.
Study context
- Population
- Cardiovascular randomized controlled trials (RCTs) (ADVANCE and LoDoCo2 trial data); representation of women2 trials
- Outcome
- Sample size requirements
Methodological detailssample size illustration using data from two cardiovascular trials
- Sample size illustration using data from two cardiovascular trials
Main finding
As reported in the abstract
- Representative participation and representative contribution to knowledge gained require relatively small increases in sample size, mainly driven by sex differences in disease rates
- Sample size requirements for RCTs powered to assess sex differences in treatment effects are unfeasibly large
Original publication
Sample size considerations to assess sex-related treatment effects. Eur Heart J. Published 22 January 2026. doi:10.
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