Blog > Why we need to enhance gender and sex diversity in clinical trials 

Why we need to enhance gender and sex diversity in clinical trials 

The healthcare industry is constantly moving towards more personalised medicine. Researchers can now perform genetic tests on people to establish which medications will work best for them, like breast cancer treatments, for example. Yet, while healthcare is moving away from a one-size-fits-all approach, it does feel like something important is still missing from the clinical research industry.  

Gender binary is a one-size-fits-all approach to healthcare 

Remember what it was like to be sat in the science classroom at school, learning about eye colour and hair colour, and how they can be explained by genetics? Can you remember how many eye colours you were taught about?  

Looking back, it’s funny really, how we learnt more about eye colour than sex and gender. Many of us will have been taught about sex and gender in a way that simply means male or female. When in fact, today, it’s much more than that.  

You might wonder why we’re using eye colour to compare with the concept of sex and gender. Well, green-eyed people make up around 2% of the global population, which is roughly the same amount of people in the world who are intersex — meaning they are effectively carrying genes that would technically be identified as both male and female by our binary system. So, why is it that we learn so much about eye colour, hair colour, and other genetic traits, but not the different sexes and genders, if the percentages within the population can be so similar?  

This binary system we were taught in school is the same one still being used in clinical research. It seems what is missing from the clinical research industry, is a lack of research into how medications perform differently in people across sex and gender spectrums. 

A new system for gender identity 

Over the last few decades, the concept of gender and sex has evolved within society — forming a new, nuanced approach in which gender is considered a spectrum. While still encompassing the binary cisgender men and women, the spectrum includes individuals who identify themselves as transgender, gender nonbinary, intersex, agender, or one of the many other identities not included under the gender binary classification system.  

Group of young diverse people smiling

According to the Williams Institute, 1.4 million U.S. adults identify as transgender, making up 0.5%-0.7% of the population. The ONS in England and Wales also released new data at the start of 2023, highlighting gender identity of the population. Of 45.7 million people (94% of the population over 16 years old), a total of 262,000 (0.5%) answered that their gender was not the same as was assigned at birth.  When compared to how many people have green eyes, you can understand how common it is not to conform to the gender binary system.   

Why it’s important to include transgender people in clinical trials 

Many transgender people take hormone therapy to affirm their gender identity, and just like many other medications, there are likely drug-drug interactions that can result in drugs working less effectively than they’re supposed to. Research has found this to be true, with some HIV medications having reduced efficacy among transgender women. Yet, transgender people aren’t often included or accounted for in clinical trials.  

Barriers to transgender participation in clinical trials 

Clinical trial designs aren’t inclusive for transgender people – The complexities of gender dysphoria are often overlooked when it comes to designing clinical trials. Especially in conditions that use gender-exclusive language like ‘women’s health’ or ‘men’s health’. Yet, transgender men can develop endometriosis, and transgender women can develop prostate cancer, but they are not considered when it comes to healthcare settings. For example, a study on endometriosis treatments will likely take place in a clinical setting where toilets are labelled women’s, the HCPs aren’t culturally safe, and there’s no mention of transgender men in the information leaflet. This is isolating and triggering for anyone who is not a woman. 

Fear of stigma being further perpetuated – Many of the clinical trials available to the transgender community are surrounding HIV treatments, which in itself is a deterrent for taking part. The transgender community are already heavily stigmatised in issues surrounding HIV, with many transgender women reporting that being seen taking part in a HIV clinical trial would lead to more stigma.  

Exclusion from clinical research – Transgender women have reported that if they were to take part in a clinical trial, they believe they would be considered as men having sex with men (MSM) instead of being recognised for their gender. Further to this, when transgender women apply to take part in clinical research as women, they are excluded based on the eligibility criteria.  

Lack of information about drug-drug interactions – As mentioned before, there is very little to no research surrounding the potential negative interactions between hormone therapy use and the clinical research drug. This causes a concern among transgender people, that clinical research drugs may not be safe for them

What needs to happen moving forward? 

One of the key facilitators to improving clinical trial participation in transgender communities is cultural safety in clinical research staff. Many transgender people have reported being put off participating due to being addressed with the wrong pronouns, or because clinical research staff didn’t know how to correctly refer to gender-affirming surgeries. Furthermore, if those who designed clinical trials also underwent cultural safety training — would clinical trial designs be more inclusive for transgender people? 

Mature LGBTQ+ friends on a laptop

If you’d like to learn more about improving diversity and inclusion in clinical trials, then take a look around our website — there are many resources to be explored.  

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