August 17, 2000New England Journal of Medicine
Enrollment of Women in Cardiovascular Clinical Trials Funded by the National Heart, Lung, and Blood Institute
Key result
Overall enrollment of women in NHLBI-funded cardiovascular trials was 54%, but excluding single-sex trials, the enrollment rate was 38% and did not change significantly over time.
Population
398,801 subjects enrolled in cardiovascular clinical trials funded by the National Heart, Lung, and Blood…
Authors
Discussion
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Member takes
Implication
Women remain underrepresented in mixed-sex NHLBI cardiovascular trials; challenges assumptions of progress and leaves open effective strategies.
Study Design
Type
Observational (n=398,801)
Structured PICO
P
Population
398,801 subjects (215,796 women and 183,005 men) enrolled in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute (NHLBI) between 1965 and 1998
O
Outcome
Enrollment rates of women compared to the sex-specific prevalence of cardiovascular disease and changes in enrollment over time
Main Result
Absolute Event Rate: 54% vs 49%
p-value: p=0.002
Federal efforts to increase female representation in cardiovascular trials have primarily succeeded due to large single-sex trials, while mixed-sex trials continue to under-enroll women without significant improvement over time.
Cite This Study
Harris et al. (2000) conducted an observational in Cardiovascular disease (n=398,801). NHLBI-funded cardiovascular clinical trials vs. Prevalence of cardiovascular disease in the general population was evaluated on Enrollment rate for women (p=0.002). Overall enrollment of women in NHLBI-funded cardiovascular trials was 54%, but excluding single-sex trials, the enrollment rate was 38% and did not change significantly over time.