Abstract 3621: Enrollment of Women in NHLBI Funded Cardiovascular Randomized Controlled Trials Fail to Meet Current Federal Mandates for Equal Inclusion
Background: Over a decade ago, underrepresentation of women subjects resulted in a NIH mandate on inclusion of women in clinical research. We sought to evaluate the impact of these guidelines on federally funded cardiovascular randomized controlled trials (CV RCT).
Methods: We searched the NIH database of clinical trials (www.clinicaltrials.gov) for phase 3 or 4 CV RCTs funded by the NHLBI with outcomes of stroke, MI, or death published between 1997–2006. We excluded trials that were still recruiting patients as of Nov 16, 2006, were observational, included children or only women, or were primary prevention trials. Relationships between enrollment of women and acuity of the trial, type of CV disease, or level of risk of the intervention were examined. Studies were classified “acute” if the research intervention was initiated during the acute phase of illness (MI, sudden death, surgery, or heart failure) and “high risk” if the tested interventions were physically invasive.
Results: Of the 982 CV studies, 203 were RCTs, 144 were phase 3 or 4 studies in adults, 58 had outcomes of interest, and only 18 were published between 1997–2006. There were 8 acute, 8 high risk, 8 CAD, 3 CHF, and 7 EPS trials. We observed no increase in the enrollment of women between 1997 – 2006 (mean 26%, range 18 – 44%). There was no association between enrollment and acuity, type of disease, or level of risk (Figure⇓).
Conclusions: Despite a federal mandate for equal inclusion in NIH sponsored trials, there continues to be an underrepresentation of women in CV RCTs. Women account for half the CV mortality in the US. Increased participation of women in acute and high risk CV RCTs remains a priority and deserves ongoing scrutiny.