Valvular & structural heart diseaseMeta-analysis
Enrollment of Older Patients, Women, and Racial and Ethnic Minority Individuals in Valvular Heart Disease Clinical Trials
- Systematic review of clinical trials
Authors' conclusion
This review found that over the past 2 decades, women and racial and ethnic minority individuals have remained underrepresented in North American valvular heart disease clinical trials.
Study context
- Population
- Published clinical trials enrolling >100 adults with valvular heart disease, 2005–2020
- Participants
- 51,527 participants · 139 trials
- Outcome
- Temporal trends in representation of older patients, women, and racial and ethnic minority individuals
Pooled result
As reported in the abstract
- Weighted mean (SD) age of enrolled patients, years
- 68.4 (11.4)
- Mean age 2005-2008 vs 2017-2020, years (nonsignificant increase)
- 61.9 (5.9) vs 72.8 (9.6); P = .09 for trend
- Overall proportion of women enrolled; no significant changes over time
- 41.1%
- Trials reporting race and ethnicity
- 13 (9.4%)
- Trial-level representation of minority groups (range)
- 0.27% to 43.9%
Further pooled results
Trial characteristics
- Aortic valve disease trials
- 103 (74%)
- Enrolled only in Europe
- 63 (45.3%)
- Enrolled only in North America
- 24 (17.3%)
- Multiple geographical regions
- 19 (13.7%)
Original publication
Enrollment of Older Patients, Women, and Racial and Ethnic Minority Individuals in Valvular Heart Disease Clinical Trials. JAMA Cardiol. Published 1 September 2023. doi:10.1001/jamacardio.2023.2098
Summarised from the published abstract; every number is checked against it