For years, women have been sidelined in healthcare, with devastating consequences for their health. Designed by men for men, medicine has long treated women as an afterthought; too ‘complex,’ and too ‘inconvenient’ to study properly.
Medicine, historically dominated by male practitioners and researchers, has often overlooked or neglected the unique physiology of women, treating them as smaller, more complex versions of men. This bias has led to a lack of data on how treatments specifically impact women and leaving women’s health concerns underdiagnosed, undertreated and frequently dismissed in healthcare.
Historical Bias in Medical Research
Medical research has long been plagued by gender bias, but more recent data between 2013-2015 shows that women made up just 29-34% of phase 1 clinical trials; the stage at which the safety and tolerability of new drugs are tested.
In 1977, the FDA recommended the exclusion of women of childbearing age from participating in clinical trials, largely in response to the thalidomide tragedy, and research trials were not required by the National Institutes of Health to include women until 1993. Thus, treatments were overwhelmingly tested on men, with the exclusion of women justified by the idea that their fluctuating hormonal cycles were simply too complex, and thus too expensive to study.
The fallout from this exclusion is far-reaching. Cardiovascular disease is the leading cause of death among women, yet between 1987 and 2012, women made up only 30% of participants in North American clinical trials for cardiovascular treatments. This gender gap continues to put women at risk, with research showing that women are 50% more likely to receive an incorrect diagnosis following a heart attack compared to men. In areas like pain management, women are more likely to suffer from chronic pain, yet to date, no pharmacological options for the management of chronic pain have been specifically developed for women.
The contraceptive gap is equally glaring. Despite being used by millions of women worldwide, hormonal birth control has seen few significant innovations since the 1960s, partly because clinical trials continue to prioritize male subjects. When non-hormonal contraceptive options were finally developed, such as Evofem's contraceptive gel, it took nearly seven years for it to receive FDA approval, highlighting the slow progress in women's healthcare.
As of 2019, women still only accounted for around 40% of clinical trial participants for the three diseases that most affect them (cancer, cardiovascular disease and psychiatric disorders), and many trials still fail to disaggregate data by sex, leaving key differences between men and women unexamined.
Structural Barriers to Women in Clinical Trials
Women face a multitude of barriers that systematically exclude them from clinical trials. Structural obstacles like trial design, exclusion criteria, and socioeconomic factors create a perfect storm that keeps women from being adequately represented in medical research.
Many clinical trials are designed with little flexibility, requiring frequent hospital visits and long-term commitments, which are simply not feasible for women balancing work, childcare, and eldercare responsibilities. This lack of adaptability in trial design forces many women to opt out before they even have a chance to participate.
Exclusion criteria compound the issue. Women who are pregnant, breastfeeding, or of childbearing age are often excluded from trials due to concerns about adverse fetal effects of treatment, even though understanding how treatments affect them is equally important.
Furthermore, socioeconomic barriers, including the costs associated with participating in trials, such as travel, lost wages, and lack of childcare, can be prohibitive, especially for women in low-income brackets. Geographic location is another significant factor, with many trials taking place far from diverse communities, making access even more difficult for women from marginalized groups.
The Impact of Gender Bias on Healthcare
Gender bias in healthcare has led to troubling disparities in diagnosis, treatment, and outcomes for women.
While women live longer than men by an average of six years, they suffer higher morbidity from acute and chronic physical and psychiatric diseases, and utilize more healthcare services, while often a lower standard of care. For instance, women are 50% more likely to be misdiagnosed following a heart attack, and are significantly less likely than men to receive aggressive interventions like angioplasty or bypass surgery. Even when women do receive these treatments, their mortality rates are higher, often because they are diagnosed later in the disease progression.
And women experience 50-75% more adverse drug reactions than men because most drugs are tested and dosed based on male physiology, failing to account for hormonal differences.
The Need for Inclusive Research & Clinical Trials
To create better healthcare, clinical trials must be designed to accommodate women’s realities. This means adjusting study protocols to include women at different stages of their hormonal cycles, offering flexible participation options that consider caregiving responsibilities, and reducing exclusion criteria that disproportionately affect women, such as those based on reproductive potential.
Elevating women's quality of life by advancing scientific understanding, innovating treatments and advocating for underdiagnosed, undertreated, and otherwise dismissed female-specific diseases, Harmonia is committed to ensuring that women are not only included but truly listened to in research and drug development. When women’s voices are integrated into the research process, the outcomes are safer and provide more effective treatments that reflect their unique health needs, helping to close the gender gaps in healthcare.
By increasing female participation in clinical trials, we move closer to personalized, equitable healthcare for everyone. When research reflect the needs of both sexes, treatments become more effective, side effects are reduced, and outcomes improve for all patients. Women’s health has been neglected for too long. It's time to prioritize inclusive research that leads to better care for everyone.
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