The Hidden Heart Crisis: Systemic Obstacles Limiting Women in Clinical Studies

Heart failure and cardiovascular disease are a significant public health burdens that impact women’s quality of life and life expectancy differently than men, even though women represent roughly half of adults diagnosed these two morbidities in the United States. This disparity often results in late diagnoses, less effective treatment outcomes, misrepresentation of symptoms, and poorer quality of life.

Despite growing awareness of the need for gender equity in clinical research, structural and systemic barriers continue to limit women's participation in cardiovascular and heart failure studies. One significant factor is the historical exclusion of women from early clinical trials, which has resulted in a lack of gender-specific data and a research infrastructure that is often ill-equipped to accommodate women's unique needs. Regulatory guidelines, such as the U.S. Food and Drug Administration's 1993 policy requiring the inclusion of women in clinical trials, have improved representation to some extent, but disparities remain in both enrollment rates and data analysis stratified by sex¹.

Another systemic issue involves eligibility criteria that unintentionally exclude women. For example, age cutoffs, comorbidity exclusions, or medication use restrictions disproportionately affect women, who are more likely to present with non-traditional symptoms or have coexisting conditions like autoimmune disorders and depression.

Additionally, trial designs often fail to account for reproductive health considerations, such as pregnancy and hormonal influences, which can deter both researchers and participants from pursuing involvement. A more inclusive design process that addresses these structural issues is essential to achieving better representation².

Cultural and Societal Influences on Trial Participation

Cultural expectations and gender norms also play a role in the underrepresentation of women in cardiovascular clinical trials. Women, particularly from minority and lower-income backgrounds, often encounter social pressure to prioritize family responsibilities over personal health needs, leading them to decline participation in time-intensive studies. Cultural mistrust of the medical system, especially among African American and Hispanic women, further diminishes willingness to enroll in trials, stemming from historical abuses and ongoing disparities in healthcare treatment³. Additionally, societal perceptions about cardiovascular disease being primarily a “man’s issue” contribute to a lack of urgency among women to seek out or participate in related clinical research. This perception is reinforced by public health messaging and media coverage that frequently highlight male patients and symptoms. As a result, women may underestimate their own risk or assume that research findings based on male participants will apply equally to them, which is not always the case. Addressing these deeply rooted cultural beliefs requires tailored education and outreach efforts that resonate with diverse female populations and emphasize the relevance of heart disease to women’s health⁴.

Reducing Practical Barriers Through Policy and Program Design

To effectively increase women's participation in cardiovascular and heart failure clinical trials, researchers and trial coordinators must proactively address practical barriers that disproportionately affect female participants. Transportation assistance is one of the most impactful strategies. Providing rideshare vouchers, shuttle services, or travel stipends can make it feasible for women without reliable transportation or those living in rural areas to attend trial appointments. Some research institutions have begun to partner with local transit authorities or community-based organizations to develop sustainable transportation solutions for trial participants⁵. Childcare and family responsibilities are another significant obstacle. Women often serve as primary caregivers, and the lack of support for dependent care during trial participation can prevent them from enrolling. Offering onsite childcare during visits or providing stipends to compensate for childcare expenses can alleviate this burden. In some cases, flexible scheduling of appointments outside normal business hours or combining