Written by Mia Thompson. Reviewed by Jake Hunter.
For a long time, medical research has predominantly focused on men, assuming that the results would be applicable to everyone. This exclusion of individuals assigned female at birth from clinical trials has created serious data voids, leading to misdiagnoses and ineffective treatments. While we’ve seen some advancements towards more gender-inclusive research policies, deep-seated biases still linger, impacting drug safety and fertility studies.
A Legacy of Exclusion
Throughout much of modern medical history, individuals assigned female at birth were systematically left out of clinical trials. Researchers often prioritized male participants due to concerns about hormonal variations and possible pregnancy risks, deeming them “easier” subjects for testing. In 1977, the US Food and Drug Administration (FDA) officially suggested that women and individuals capable of becoming pregnant should be excluded from early clinical research—a guideline that lasted over ten years.
This bias was similarly prevalent in the UK, where research historically focused on male physiology, resulting in treatments developed without proper testing on individuals assigned female at birth. Although the 1990s brought about a shift, largely due to pressure from organizations like the European Medicines Agency (EMA), the impacts of decades of male-centric research continue to shape modern medical practices.
The Data Shortfall: When Science Misses Half the Population
The exclusion of individuals assigned female at birth from clinical trials has had enduring repercussions. A key issue is the failure to recognize sex-based differences in how drugs are metabolized. Women are nearly twice as likely to experience adverse drug reactions compared to men, mainly because clinical trials still tend to focus on male participants.
Take cardiovascular disease, for example—historically labeled a “man’s disease,” most research has centered on individuals assigned male at birth. This has resulted in a lack of understanding regarding heart attack symptoms in women, leading to frequent misdiagnoses. The British Heart Foundation (BHF) reports that thousands of women in the UK die each year due to being incorrectly diagnosed and treated.
Conditions like ADHD and autoimmune diseases are also frequently studied in men, despite affecting women at higher rates. A recent investigation by University College London pointed out that ADHD is often underdiagnosed in those assigned female at birth because diagnostic criteria are based on male presentations of the condition.
Fertility & Reproductive Health: A Research Blind Spot
While women have faced exclusion from many clinical trials, research on individuals assigned female at birth has often been limited to reproductive health. Sadly, even within this arena, substantial gaps persist.
Polycystic ovary syndrome (PCOS), affecting approximately 1 in 10 women in the UK, is still under-researched despite its ties to infertility and cardiovascular issues. Meanwhile, endometriosis is another painful condition that averages eight years for a diagnosis in the UK, largely due to insufficient clinical awareness and funding.
Fertility research itself has also been impacted by these biases. Much of the focus has been on sperm health, with studies on egg quality and the influence of lifestyle factors on female fertility receiving far less attention. This imbalance perpetuates outdated ideas that fertility challenges primarily concern women, while failing to deliver adequate scientific insights for all those trying to conceive. If you’re curious about some of the ways to assist in this process, check out the BabyMaker at Home Insemination Kit, which is a reliable resource on the subject.
Navigating the Path to Conception: Missing Insights
IVF protocols often rely on standardized approaches rather than personalized treatments, largely due to a lack of diversity in clinical trial subjects. This can lead to patients undergoing unnecessary or ineffective treatments before discovering the right method for them.
What Needs to Change?
To remedy these disparities, clinical trials must routinely include sex-based analyses instead of reverting to male-centric models. The Medicines and Healthcare Regulatory Agency in the UK has begun to emphasize the importance of this change. For more information on addressing infertility and related topics, you can refer to this excellent resource on the matter.
In conclusion, the medical field must continue pushing for inclusive research practices that account for all individuals, ensuring that no one is left behind in the quest for effective treatments.