Campaign Promotes Enrollment of Women in CVD Device Clinical Trials
"Take Her Health to Heart" is a public awareness campaign built from a coalition of representatives spanning all sectors of the health care industry with the goal to promote equitable enrollment of women in cardiovascular device clinical trials. This includes women in cardiology passionate about this mission and spanning all career stages, from fellows in training to early career and established faculty. To promote physician awareness within cardiology, this initiative has been presented at the regional Midwest ACC Women in Cardiology conference, Cardiovascular Research Technologies (CRT) and AdvaMed.
More specifically, the group highlights how cardiovascular disease is the leading cause of death in females, and many physicians are underinformed about women's cardiovascular disease burden and clinical presentation. Only 8% of primary care physicians, 13% of gynecologists and 17% of cardiologists are aware of cardiovascular disease as a greater cause of death in women as compared to men.1 The gender disparities in clinical trial enrollment are staggering, as traditionally women comprise only about one third of total enrollment, when cardiovascular disease prevalence is above 50%. Additionally, only about 35% of recent primary device trials include sex-specific outcomes.2,3 Despite numerous initiatives, we have seen no meaningful improvement over the past two decades.4-7 It is key to note that there are both patient and physician barriers that hinder female enrollment. Female patients are more likely to have trust concerns, different decision-making habits and risk tolerances. Physicians may misdiagnose cardiovascular disease when women present with atypical symptoms, may speak in too much medical jargon and may be unaware of current trials.8 In addition, fewer female primary investigators may be another barrier, which may be overcome by promoting female cardiologists as lead investigators, as recently demonstrated in a study of major heart failure trials.9
Established in 2015, this coalition aims to better understand these barriers and develop creative solutions for the goal of encouraging female recruitment, enrollment and retention in cardiovascular device clinical trials. The team is comprised of, among others, the trade association, AdvaMed, leading female cardiologists, and clinical and research societies, including Healthy Woman, Women as One, the Society for Cardiovascular Angiography and Interventions, American Heart Association (AHA), the American Women's Medical Association, the ACC and the U.S. Food and Drug Administration (FDA).
The group first convened at CRT 2016 and then at the 2019 AHA Scientific Sessions and again at CRT 2020 to develop related objectives and strategies to achieve these goals. Several initiatives have been undertaken since then, including a publication in the Journal of the American College of Cardiology detailing this disparity. The group implemented infographics for flyers and patient education flyers for physician practices and social media. A slide deck has been developed to educate clinical trial site teams about the barriers to female enrollments as well as practical tools and tricks to improve female enrollment, and medical device industry members and clinical research societies are working to incorporate this educational slide deck into the recruitment strategy for upcoming trials.
In addition, the group is planning collaborations with CardioSmart to develop further patient resources. Partnership and collaboration with the FDA to promote awareness and application of their sex-specific guidance for clinical trial design, a key initiative at FDA, is ongoing. This initiative is striving to move the needle forward by leveraging a multifaceted approach involving all key stakeholders. Learn more here.
1. Mosca L, Linfante AH, Benjamin EJ, et al. National study of physician awareness and adherence to cardiovascular disease prevention guidelines. Circulation. 2005;111(4):499-510.
2. Melloni C, Berger JS, Wang TY, et al. Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3(2):135-142.
3. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4(2):165-171.
4. Park SJ, Ahn JM, Kim YH, et al. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med. 2015;372(13):1204-1212.
5. Park SJ, Milano CA, Tatooles AJ, et al. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5(2):241-248.
6. Zusterzeel R, Selzman KA, Sanders WE, et al. Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data. JAMA Intern Med. 2014;174(8):1340-1348.
7. Holmes DR, Jr., Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.
8. Ghare MI, Chandrasekhar J, Mehran R, Ng V, Grines C, Lansky A. Sex Disparities in Cardiovascular Device Evaluations. JACC: Cardiovascular Interventions. 2019;12(3):301-308.
9. Reza N, Tahhan AS, Mahmud N, et al. Representation of Women Authors in International Heart Failure Guidelines and Contemporary Clinical Trials. Circ Heart Fail. 2020;13(8):e006605.
This article was authored by Katherine Clark, MD, Fellow in Training at Yale School of Medicine in New Haven, CT.