Author + information
- Received February 26, 2018
- Revision received September 30, 2018
- Accepted October 4, 2018
- Published online February 4, 2019.
- M. Imran Ghare, BSa,
- Jaya Chandrasekhar, MBBSb,
- Roxana Mehran, MDb,
- Vivian Ng, MDc,
- Cindy Grines, MDd and
- Alexandra Lansky, MDa,e,∗ ()
- aDivision of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- bIcahn School of Medicine at Mount Sinai, New York, New York
- cDivision of Cardiology, Department of Internal Medicine, Columbia University Medical Center, New York, New York
- dDepartment of Cardiology, Northwell Health North Shore University Hospital, Manhasset, New York
- eBARTS Heart Center, St. Bartholomew’s Hospital, and the William Harvey Research Institute, Queen Mary University of London, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Alexandra Lansky, Yale University School of Medicine, 1 Church Street, Suite 330/P.O. Box 208017, New Haven, Connecticut 06520.
Women have historically been underrepresented in clinical trials evaluating cardiovascular devices. Existing initiatives through government agencies have made some progress, but contemporary rates of female clinical trial participation leave much room for improvement. This position paper provides a narrative review and investigates reasons for the underrepresentation of women in cardiovascular trials. The observed differences in safety and/or effectiveness of devices in women warrant a campaign to increase their trial participation with the aim of better understanding and improving outcomes. The authors propose a multifaceted approach to increasing female enrollment through the development of a national public awareness and education campaign aimed to inform women, clinician-providers, and clinical research personnel of these differences. Finally, the authors visit some barriers relevant to women and recommend ways to facilitate their participation in clinical trials through multistakeholder engagement.
- cardiovascular devices
- cardiovascular disease
- clinical trials
- coronary artery disease
Dr. Ghare is funded by the Yale University School of Medicine Medical Research Fellowship. Dr. Mehran has received institutional grant support from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, and OrbusNeich; is a consultant to Abbott Vascular, Boston Scientific, CardioKinetix, Cardiovascular Systems, Medscape, Shanghai Bracco Sine Pharmaceutical, and Spectranetics; receives executive committee or advisory board funding from Janssen Pharmaceuticals, Osprey Medical, Bristol-Myers Squibb; receives medical monitor funding from Claret Medical; receives Data and Safety Monitoring Board membership funding from Watermark Research Partners; and has <1% equity in Claret Medical and Elixir Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. This paper is endorsed by the Society for Cardiovascular Angiography and Interventions.
- Received February 26, 2018.
- Revision received September 30, 2018.
- Accepted October 4, 2018.
- 2019 American College of Cardiology Foundation
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