Enrollment of Women in National Heart, Lung, and Blood Institute-Funded Cardiovascular Randomized Controlled Trials Fails to Meet Current Federal Mandates for Inclusion

• Published in: Journal of the American College of Cardiology Vol. 52; no. 8; pp. 672 - 673
• Main Authors: Kim, Esther S.H., MD, MPH, Carrigan, Thomas P., MD, Menon, Venu, MD, FACC
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 19.08.2008; Elsevier Limited
• Subjects: Cardiology; Cardiovascular; Cardiovascular disease; Clinical trials; Female; Heart attacks; Humans; Internal Medicine; National Heart, Lung, and Blood Institute (U.S.) - economics; National Heart, Lung, and Blood Institute (U.S.) - statistics & numerical data; Patient Selection; Randomized Controlled Trials as Topic - standards; Research Support as Topic; United States; Women; Womens health; United States
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2008.05.025

Gender-specific prevalence data were not available from the AHA report for sudden cardiac death. [...]data from the AVID (Antiarrhythmics Vs Implantable Defibrillators) (3) and MUSTT (Multicenter Unsustained Tachycardia Trial) (4) registry papers and a large population-based retrospective cohort study of all out-of-hospital cardiac arrests in Seattle and neighboring King County, Washington (5), were used. [...]the enrollment of women in overall NIH trials has increased significantly since 1993 such that more women than men were enrolled in NIH-sponsored phase 3 clinical trials (10), but our study shows that, in mixed-gender CV RCTs, women are still underrepresented.