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It's High Time for Gender-Inclusive Clinical Research

<ѻýҕl class="mpt-content-deck">— Health decisions must account for all types of bodies and identities
MedpageToday
A photo of a stethoscope laying on an LGBTQ+ flag.
Kim and Wilson are medical students.

White men have been valued as primary subjects of consensual medical research, therefore harming racial minorities, women, the transgender and nonbinary populations, and intersex individuals. In the U.S., women were not required to be included in clinical research until the National Institutes of Health (NIH) passed the . Yet even today among conditions that disproportionately affect women, studies focused on a given disease's are . In fact, in almost three-quarters of the cases where a disease affects primarily one gender, the funding . Findings extracted from analyses primarily of men may not apply to other genders, who experience unique biological, behavioral, and social contexts; yet, this research informs broad guidelines that inform medical decisions.

While various institutions have attempted to make toward studying genders more equitably, disparities persist. Further, inclusion mandates are , meaning that current research can still cater to the same privileged demographics. This begs the question: who does the clinical research industry believe deserves to be healthy?

This sentiment is reflected in current data. Our precursory analysis of the NIH's top 2,000 highest-funded projects over the past 3 fiscal years revealed an astoundingly low proportion of studies pertaining specifically to the health of women, non-binary, transgender, and intersex people. These studies account for less than 2% of the total dollar value of funding of all the projects we analyzed. Despite a from the NIH Office of Research on Women's Health to advancing research relevant to the "health of all women and all people assigned female at birth," such studies continue to receive minimal space amongst the NIH's top-funded projects.

When medical research takes only certain bodies into account when making health decisions, we all suffer. For example, cardiovascular diseases, the of death and disability globally, are still as they relate to sex and gender. Given that they cause in the U.S., further insight into how they impact understudied populations could improve the well-being of millions. Further, the lack of research on malignancies that tend to affect female organs (such as ovaries) reflects a misogyny that impacts not only cis individuals but any individual with those body parts.

To accurately promote health across all genders, including gender minorities, it is crucial not to equate sex -- the different biological and physiological characteristics of males and females -- and gender -- the socially constructed characteristics of women and men. We must recognize that each carries distinct social, anatomic, or behavioral contributions to health. Gender medicine-related research has historically been criticized for its of sex and gender and the interchangeable use of the terms. For instance, while the CDC that the definition of men who have sex with men (MSM) can be adjusted based on whether "man" refers to sex at birth or current gender identity, the current sexual practice guidelines for MSM are put forth homogeneously, irrespective of anatomy. A more precise would be specific to the body parts involved in sexual activity rather than using the gendered assumption that those with penises identify as men.

The transgender population, which was by the Institute of Medicine in 2011 as an understudied population in critical need of further research, continues to face unique health disparities. Transgender people may avoid medical care for reasons such as , encountering , or with the process. Significant differences have been in screenings for colorectal, prostate, and cervical cancer between trans and cis individuals. Additionally, the rates of conditions such as asthma and certain mental health disorders are much higher in transgender individuals. Unfortunately, the faced by this population in the healthcare system, at the hands of both individual providers and businesses like insurance companies, further restricts access to care which can compound disparities.

While more research is needed to properly guide policy regarding screening for individuals of different gender identities, a crucial first step toward health equity is working for a more inclusive health system for individuals of all genders and identities. Clinical research findings can inform our understanding of everything from risk factors to interventions, allowing us to provide up-to-date and knowledgeable care. It's important to note that many become involved in clinical research after discussion with their own doctors. The lack of inclusion may be a result of a lack of recruitment, which itself is a failure of our healthcare system.

Given the vast resources of modern medicine, evidence-based medical care should be a right. This should apply not only to demographics who have been historically privileged but especially to those who have been previously harmed by our healthcare system. True equity means not just including diverse patients in clinical trials but creating a safe, affirming space for individuals of different identities to receive care every day. Understudied genders and other -- including racial and ethnic minorities, those in rural areas, individuals of lower social and economic status, refugees and immigrant groups, the incarcerated, and the elderly -- deserve to live full and healthy lives. We owe it to them to create healthcare spaces that make this possible, from clinical trials to insurance policies to primary care offices.

and are medical students at the Albert Einstein College of Medicine in New York City.