Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives.

Although some progress has been made in the last 3 decades to increase the number of women in clinical cardiology trials, review of recent cardiovascular literature demonstrates that women and underrepresented minority women are still underrepresented in most clinical cardiology trials. This is especially notable in trials of patients with coronary artery disease, heart failure with reduced ejection fraction, and arrhythmia studies, especially those involving devices and procedures. Despite the call from National Institutes of Health, Food and Drug Administration, Institute of Medicine, and various professional societies, the gap remains. This paper seeks to identify the barriers for low enrollment and retention from patient, clinician, research team, study design, and system perspectives, and offers recommendations to improve recruitment and retention in the current era.
Competing Interests: Funding Support and Author Disclosures Dr Cho has received institutional research grants from Esperion, Novartis, AstraZeneca, and Amgen; and has been a consultant for Esperion, Amgen, and AstraZeneca. Dr Vest has received institutional research grants from Boehringer Ingelheim, CareDx, and Corvia. Dr O’Donoghue has received institutional research grants from Amgen, Novartis, AstraZeneca, Medimmune, Intarcia, and Merck; and has received honoraria from Amgen, Novartis, Janssen, AstraZeneca, and CRICO. Dr Ogunniyi has received institutional research grants from AstraZeneca, Boehringer Ingelheim, and Zoll; and has been a consultant for Pfizer. Dr Sarma has received an institutional research grant from CRICO. Dr Poole has received institutional research grants from AtriCure, Kestra, and Biotronic. Dr Mehran has received institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and Zoll; has received consultant fees from Boston Scientific, Cine-Med Research, Janssen Scientific Affairs, Medscape/WebMD; has had consultant fees paid to the institution from Abbott Laboratories, Abiomed (spouse), Bayer (spouse), Beth Israel Deaconess, Bristol Myers Squibb, CardiaWave, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Spectranetics/Philips/Volcano Corp; holds equity in Applied Therapeutics, Claret Medical, Elixir Medical, STEL, CONTROLRAD (spouse); and has been consultant (no fee) for Regeneron Pharmaceutical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)