Dr Linda Worrall-Carter, Founder & Director of Her Heart
Introduction: Heart disease is a pervasive health issue affecting millions globally, but the under-representation of women in cardiovascular clinical trials remains a significant challenge. This blog explores the critical issues highlighted by Vogel et al, in The Lancet. This comprehensive paper sheds light on the knowledge gaps, reasons behind women’s reluctance to participate, and actionable strategies to address this disparity.
The Knowledge Gap: Despite advancements in cardiovascular research, there’s a conspicuous lack of foundational knowledge regarding the pathogenesis, pathophysiology, and natural history of cardiovascular disease in women. Comprehensive sex-specific data are scarce, and women remain underrepresented in clinical trials, leading to uncertainties about the efficacy and safety of therapies compared to their male counterparts.
There is considerable work to be done to investigate why women are under-represented in cardiovascular clinical trial participation, including why women are less likely than men to be considered for screening in trials, and also the reasons why women might be less likely than men to consider participating. Vogel et al found issues of mistrust as well as barriers such as the lack of time – due to caring responsibilities. More efforts are needed to identify strategies that make participation in trials not only more inclusive of women but more accessible for women.
The need for Closing the Gap:
- Increase Women’s Participation:
- Adjust exclusion criteria: Modify criteria to ensure inclusivity and relevance to women’s health, allowing a broader spectrum of participants.
- Partner with stakeholders: Collaborate with diverse stakeholders to investigate and address structural and economic barriers. Implementing flexible hours for recruitment and at-home follow-ups can facilitate increased participation.
- Power Cardiovascular Clinical Trials for Sex-Specific Analyses:
- Ensuring that trials are powered correctly to identify haemodynamic and pharmacology that are specific to women.
- This will allow for sex-specific treatment algorithms, targets that establish norms specific to women and appropriate management strategies can be developed.
- Sex-specific treatment algorithms also empower healthcare providers with the knowledge to offer gender-specific treatments based on accurate data.
- Initiate Research on Biological Pathways:
- Explore potential biological pathways: Investigate how sex and gender act as determinants of cardiovascular health, contributing to the evidence base for improved guideline recommendations for risk factor assessment.
- Investigate Under-Recognized Factors:
- Study sex-specific and under-recognized factors: Understand the impact of these factors on cardiovascular risk in women, providing the necessary evidence for enhanced risk factor assessments.
Conclusion: Addressing the under-representation of women in cardiovascular trials is imperative for advancing our understanding of heart disease in women. By implementing these strategies, we can close knowledge gaps, encourage women’s participation in clinical trials, and ultimately empower healthcare providers with the insights needed to deliver personalized and effective care for women’s heart health. It’s time to bridge the gender gap in cardiovascular research and pave the way for a healthier future for all.
Reference: Vogel et al (2021) The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030; The Lancet June 2021,397 (10292) 2385-2438