KEY TAKEAWAYS:
• Historical gender bias in research: For much of modern medical history, clinical trials primarily enrolled men, leading to diagnostic criteria, dosing guidelines and symptom profiles based on male biology. This exclusion has caused significant healthcare disparities for women.
• Consequences of research gaps: Women face higher rates of adverse drug reactions, misdiagnoses and dismissals in healthcare. Conditions like heart disease, ADHD and autoimmune diseases often present differently in women, yet they remain under-researched and misunderstood.
• Advocating for change: While systemic changes are underway, women can take immediate steps to advocate for their health by being persistent, asking direct questions and seeking collaborative healthcare providers who prioritize inclusive care.
SUMMARY:
This article explores the historical exclusion of women from clinical trials and its ongoing impact on women’s healthcare. Gender bias in research has led to significant disparities, including misdiagnoses, unsafe treatments and overlooked conditions. Even though there are significant strides being made to improve inclusivity in medical research, some disparities remain. Because of these, it’s just as important now for women to understand how to advocate for themselves in medical settings, ensuring that health concerns are taken seriously.
If you have ever left a doctor’s appointment feeling dismissed, misdiagnosed or under-treated, you are not alone. Many women have experienced this frustrating reality, and the cause lies in the research. For much of modern medical history, clinical trials were not designed with women in mind. Instead, researchers routinely enrolled men as the default study subjects. As a result, many of the dosing guidelines, diagnostic criteria, and symptom profiles still used today were shaped by male biology — not women’s unique needs.
This deep-rooted gender bias in medicine has created significant healthcare disparities. However, understanding this history is the first step toward changing it. Explore how women were excluded from research, what the medical community is doing differently now and how you can best advocate for yourself.
How we got here: The historical research gap
The exclusion of women from medical research was not a random oversight. It was a combination of societal biases, protective measures and intentional policy decisions. The use of thalidomide, a drug widely prescribed in the 1950s and ‘60s for nausea during pregnancy, resulted in severe birth defects in thousands of children in the ‘60s. As a direct result of the thalidomide crisis, the Food and Drug Administration (FDA) made the removal of women from studies a formal practice.
“Women’s exclusion from research became intentional after the Food and Drug Administration issued a policy guideline in 1977, where they required that women of childbearing potential be excluded from early phase clinical trials,” Jennifer Sexton, research operations director at the OhioHealth Research Institute, explains.
While the FDA intended to protect women and potential pregnancies from adverse drug effects, this overly cautious response had profound, long-term implications for women’s health. Not only did it limit the focus on women’s health needs, but also reduced the amount of research specifically examining how diseases and treatments affect women differently.
Mona Prasad, DO, a maternal-fetal medicine physician at OhioHealth, notes that excluding women from studies often also made the studies more feasible and efficient. “Research is often done based on what’s feasible and clean, so historically, it was easier to exclude women rather than prove they weren’t pregnant,” Dr. Prasad says.
Although significant progress has been made in advancing the inclusion of women in research studies since the 1970s, a gap remains. “Only about 40 percent of clinical trial participants are women, while women make up 51 percent of the US population,” says Sexton. “Women made up less than 40 percent of the participants in heart disease studies compared to being 49 percent of that population.” Similar differences can be observed in cancer, psychiatry and Alzheimer’s studies, to name a few.
Consequences of the research gender bias
This gender bias in clinical trials means that many medications and treatments were never adequately tested on the people who would ultimately use them. “The underrepresentation of women in research leads to significant health inequities, including delays in diagnosing disease and treatments that are ineffective or unsafe for women,” Sexton notes.
For example, an article published by the Association of American Medical Colleges showed women experience adverse drug reactions at a rate nearly twice that of men. And devices such as metal hip replacements have been found to fail at much higher rates in women — one study found women were 29% more likely than men to experience implant failure.
Beyond adverse effects, women have historically faced common misdiagnoses and dismissals. Dr. Prasad shares that heart disease is a classic example: “Heart attacks can present very differently in women than men, and women’s symptoms are often dismissed in emergency settings because they don’t align with the male-based criteria.” Instead of the expected chest pain, women may experience subtle symptoms such as nausea, fatigue or back pain, which can be overlooked or attributed to less critical conditions.
Other conditions commonly misdiagnosed or overlooked in women include autoimmune diseases, depression, anxiety and attention-deficit/hyperactivity disorder (ADHD). “Women with ADHD are often misdiagnosed with anxiety or depression, leading to delays in appropriate treatment,” explains Dr. Prasad. Autoimmune diseases frequently affect women, but because their presentation can be nuanced and take years to diagnose, women are left feeling unheard or forced to repeatedly advocate for answers. Ongoing gaps like these reveal the impact of legacy research practices.
What is changing today
The medical community is actively working to correct these historical healthcare disparities. Federal regulations and local initiatives are driving intentional change to ensure women and minorities are properly represented in clinical research.
The National Institutes of Health (NIH) now requires researchers to include women in studies or provide a valid rationale for excluding them. This NIH policy became a federal law in 1993, effectively reversing the FDA’s guidelines from the ‘70s.
Additionally, the FDA is now encouraging the use and development of more pragmatic trial designs. “Typically, traditional clinical trial designs are very rigid. Visits have to happen within very narrow time frames,” explains Sexton. “But people go on vacation. They get sick. They forget or need to reschedule appointments.” Pragmatic trials have more flexible frameworks that better reflect typical patient experiences, making it easier for more diverse populations to participate.
OhioHealth is dedicated to fostering healthier communities by prioritizing inclusive research. “OhioHealth has convened research steering committees in each clinical area to ensure the studies we do align with our vision to conduct ethical, efficient and impactful research,” Sexton says. “One of the key criteria for approving new studies is evaluating whether the research is adequately inclusive for women and minorities.” The OhioHealth Research Institute also works closely with physicians to identify gaps in their research portfolios and source new studies to fill those gaps, ensuring they’re meeting the needs of OhioHealth patients.
How to advocate for yourself at your next appointment
Dr. Prasad points out that, because of the lack of research and historical biases, society often conditions women to accept discomfort and physical pain. “The discomfort normalized for women, from menstrual cycles to childbirth, is often dismissed as something to endure, rather than a problem to solve,” she says.
Navigating a medical system built on male biology requires clear communication, persistence and a proactive approach. All women deserve their health and wellness concerns to be taken seriously.
While systemic changes take time, you can take steps to advocate for your health:
- Be persistent: “Persistence is key. Bring notes, questions or even family members to appointments, and don’t hesitate to share what you’re most worried about,” Dr. Prasad advises.
- State your main concern immediately: Tell your doctor exactly what you’re worried about at the start of the visit. This helps your physician understand your perspective and tailor their evaluation to address your specific fears.
- Ask direct, detailed questions: If a treatment plan does not feel right, ask how the prescribed medication or procedure affects women specifically.
- Seek a collaborative partner: Find a physician who engages in bidirectional communication. You should feel like an active participant in your care, not just a passive listener.
Demand the care you deserve
Understanding historical gender bias in medical research is crucial to recognizing its impact on women’s healthcare today. While progress has been made to address these disparities, there is still work to be done to ensure equitable representation in clinical studies and personalized care for women. By staying informed, advocating for yourself and seeking providers who prioritize inclusive research and collaborative care, you can play an active role in bridging these gaps. Your health and voice matter — be persistent, ask questions and empower yourself to demand the care you deserve.
Frequently Asked Questions
What is gender bias in medicine?
Gender bias in medicine refers to the historical focus on male participants in clinical trials, leading to healthcare disparities for women.
Are women adequately represented in clinical trials today?
No, women — particularly women of color — remain underrepresented, making up about 40% of clinical trial participants.
What are the consequences of male-dominant research?
Women face delayed diagnoses, ineffective treatments, and higher rates of adverse drug reactions due to insufficient female-focused research.
How can women advocate for better healthcare?
By asking specific questions, bringing notes to appointments, and selecting collaborative providers, women can advocate for improved, personalized care.
What are pragmatic clinical trial designs?
These are flexible trial designs that mimic real-world patient experiences, aiming to improve diversity and inclusivity in research.
