The Truth About Female Representation in Research Studies

There is a clear and consistent gender bias in the research world. Before the passage of the National Institutes of Health’s Revitalization Act (NIHRA) in 1993, researchers were often instructed by their institutions to base their work and assumptions on male subjects. The NIHRA requires that all government-funded research includes women and people of color as participants in clinical trials, or an explanation as to why either sex was excluded. In 2001 , the NIH began enforcing the practice of valid analyses of the sexes in clinical trials “as fully as it implements other elements of the inclusion policy.” In 2017 an amendment was passed mandating all Phase III Clinical Trials to include this information when registering on Clinicaltrials.gov. So why is there still a research bias against female participants? Studies are getting around this requirement because only government-funded studies must include both sexes, and most research studies are funded by private pharmaceutical companies that are not required to follow these standards. The FDA’s requirement also states that female participants simply need to be included in research, but there is no mandate that participant ratios should be reflective of the real-world burden of the disease/disorder in women.

Underrepresentation in Preclinical and Translational Research

In 2014, a study was conducted to analyze sex bias in preclinical and translational research, i.e., animal and cell studies. These studies precede clinical trials on human participants, so it is important that sex be considered in this research in order to guide future studies. The study found that 80% of animal studies that specified sex only used males, while 17% used only females, and 3% used both. Similar numbers were found in cell studies. Perhaps most shockingly, in studies that looked at female-prevalent diseases, 44% of studies did not specify the sex studied, and out of the studies that did specify sex, only 12% used female animals.

Health Consequences for Women

The underrepresentation of female participants in research studies can lead to serious health consequences, as many women experience different symptoms than men with the same diagnosis. This disparity in symptom recognition can result in misdiagnosis, delayed medical care, and even death. In 2013, the FDA released a statement recognizing the incorrect therapeutic dosage of Ambien, and that this dosage should be cut in half for women. For years, women had been told that 10mg of Ambien is suitable to treat insomnia, the same dosage recommended for men. Because it takes women longer to eliminate Ambien from their bodies, the effects were too long-lasting and resulted in extreme and dangerous drowsiness upon waking. More than a dozen women who took these high levels of Ambien reported cases of “sleep driving,” a form of sleepwalking where women drive their cars without consciously deciding to do so. This issue was even highlighted in HBO’s drama series Big Little Lies. There are also social barriers that contribute to the lack of female participants in research. Many male doctors tend to take women less seriously when women describe their symptoms, and are prone to misdiagnosis, especially when it comes to pain. A 2017 study showed that women were up to three times more likely to die following a serious heart attack than men due to differences in symptom presentation (this is known as Yentl Syndrome in the medical community). Women were less likely than men to be given the same diagnostic tests, receive bypass surgeries for blocked arteries, and to be prescribed medications that can prevent a second heart attack, despite the fact that these treatments are recommended for both sexes. When women were appropriately given these treatments , the gap in mortality decreased significantly. The exclusion of women from research studies is also intersectional — women of color, queer women, elderly women, transgender women and transgender, intersex or nonbinary people who were assigned female at birth (AFAB) tend to be left out of participant selection. Even in studies that are analyzing female-focused issues, these groups of women are highly underrepresented. This is most clear in the case of high mortality rates due to childbirth complications in black women . The cause of this higher rate is unknown, but doctors who are trained primarily with white patients do not always recognize the symptoms of childbirth complications in black women until it is too late.

What Next?

In order to combat the underrepresentation of women in scientific research, there must be a shift in the viewpoint that males are the “default” or “normal” biological version, and females are “complex.” This not only affects women’s health, but also decreases the validity of modern medicine. By limiting the research pool of participants, researchers are losing valuable data. Analyzing hormonal and neuronal sex differences can open new therapeutic avenues for the treatment of all people, not just women.

Call To Action

1. Reach out to your doctor or healthcare provider and ask if there are ways to get involved in clinical trials.

2. Visit https://clinicaltrials.gov/ to find clinical research studies near you.

3. Spread the word and inform family and friends about the potential benefits of getting involved in research studies as a woman and/or minority.

–Hannah Lichtenstein, Guest Writer

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