A Gap in Research: The Ongoing Issue of Gender Disparity in Clinical Trials

As the medical field has come to better understand gender disparities, the startling realization has emerged that many medications on the market today were deemed effective without being thoroughly researched on women.

Katy Fallon
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Despite women making up half of the globe’s population, there’s a prevalent gap in women’s representation in healthcare. Historically, males have been treated as the default when it comes to understanding diseases and testing medicine. As the medical field has come to better understand sex differences, the startling realization has emerged that many medications on the market today were deemed effective without being thoroughly researched on women. Neglecting to represent women in clinical research means missing out on crucial understandings in drug efficacy and sex-specific disease symptoms. 

Cardiovascular disease (CVD) is the leading cause of death in both men and women. Symptoms vary vastly depending on one’s sex but symptoms that women report are categorized as “atypical", leading to a higher prevalence of mis-diagnosis amongst women. Given that “Women’s health is considered a niche market and mere subset of healthcare,” they’re underrepresented in broader (not female specific) medical studies, leaving their symptoms and needs more difficult for professionals to recognize. In addition to enrolling fewer women in trials, female risk factors like menopause and contraceptive pills are largely under studied in relation to CVD.  One recent study found that only 1.6% of CVD trials analyzed female risk factors. With female physiology being unique from male physiology, the demand for comprehensive research in women’s health is critical. 

The lack of female representation in cardiology studies prevails beyond participants; this trend exists in those leading the trials as well. Dr. Mary Norine Walsh addressed this recently after noting that 93% of the presenters at the American College of Cardiology 70th annual scientific sessions were men. Of the trials that were presented by women, all of the studies were explicitly looking into risk factors pertaining to women only, accentuating the scarcity in incorporating women’s health in broader clinical research. The change towards gender inclusivity requires more than individual efforts. “This comes down to senior clinical trialists relinquishing the podium and giving a leg up to others," said Walsh. 

While the gender disparity in cardiology research is amongst the most visible, it’s by no means the only therapeutic area demanding change. Even in female-specific disease areas underrepresentation endures, putting women’s health at risk. Black women are three times more likely to develop breast cancer, for example, but make up only 3% of clinical trials, resulting in treatments being prescribed without having been thoroughly tested. Given that Black women are 41% more likely to die of breast cancer, the absence of representation in trials is dire. “The only way we’re going to change those numbers is to get drugs that work with our bodies,” said trial representation advocate Ricki Fairley

As more women are raising their voices and bringing attention to the gender disparity in research, trends in the industry are emerging and suggesting change. Organizations like When We Tri(al) are fighting for increased representation. When We Tri(al) is a collaboration between Touch, Black Breast Cancer Alliance and breastcancer.org dedicated to increasing the presence of Black women in breast cancer research and eradicating the disproportionate cancer rates. Additionally, in February, the FDA introduced the DEPICT Act, a bill dedicated to boosting diversity across clinical trials. With this in place, there will be more transparency in trials regarding the demographic breakdown of participants and improve drugmakers’ abilities to test the efficacy of medications on women. Changes and movements like these are finally shifting the clinical trial industry towards gender equity, challenging the current norm and prioritizing female representation in trials. 

Inato’s mission is to improve clinical trial access for all by challenging the norm and increasing representation in trials.

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