Women’s Participation in Cardiovascular Clinical Trials From 2010 to 2017
Authors' conclusion
Among cardiovascular trials in the current decade, men still predominate overall, but the representation of women varies with disease and trial characteristics, and has improved in stroke and heart failure trials.
Study context
- Population
- Completed CV trials registered in ClinicalTrials.gov, 2010–2017
- Participants
- 862,652 participants740 trials
- Outcome
- Participation of women: female-to-male ratio per trial and participation prevalence ratio (% women among participants / % women in disease population; 0.8–1.2 = good representation)
Methodological detailssystematic assessment of ClinicalTrials.gov registry
- Systematic assessment of ClinicalTrials.gov registry
Main finding
As reported in the abstract
Participation of women
- Women among trial participants
- 38.2%
- Median female-to-male ratio per trial (25th quartile 0.32; 75th quartile 0.90)
- 0.51
- Female-to-male ratio by age: ≤55 y vs 61–65 y
- 1.02 vs 0.40
- Female-to-male ratio by intervention: procedural vs lifestyle
- 0.44 vs 0.78
- Female-to-male ratio by disease: ACS vs pulmonary hypertension
- 0.34 vs 3.20
- Female-to-male ratio by region: Western Pacific vs Americas
- 0.45 vs 0.55
- Female-to-male ratio by sponsor: government-funded vs multiple sponsors
- 0.14 vs 0.73
- Female-to-male ratio by trial size: smaller (n≤47) vs larger (n≥399)
- 0.56 vs 0.49
- Participation prevalence ratio lower for arrhythmia, CHD, ACS and HF trials
- 0.48 to 0.78
Observational data: associations, not effects.
Further findings
Change in participation prevalence ratio, 2013–2017 vs previous periods
- Significant increase in stroke trials
- P = 0.007
- Significant increase in HF trials
- P = 0.01
Original publication
Women’s Participation in Cardiovascular Clinical Trials From 2010 to 2017. Circulation. Published 17 February 2020. doi:10.
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