Diversity in clinical trials is an even bigger topic this year, with the sector looking for ways to increase representation in their studies to better reflect the real world. And another facet of boosting diversity is including transgender and nonbinary participants.

Yet there are many obstacles. Trans and nonbinary people already go to numerous medical appointments and adding clinical trial commitments can be an added burden, says Parexel senior consultant of management development Liam Paschall.

Some transgender individuals take hormone replacement therapy that requires constant lab work, while some also choose to have gender-affirming surgery. Finding the right medical doctor for their needs, particularly ones that specialise in gender-affirming care, is already difficult, he adds.

Further, there is also distrust in the healthcare system. Paschall explains: “When trans patients look for a doctor, the first thing they want to know is if they will be cared for with compassion and understanding. Some clinicians may have little to no training in addressing their needs. And when they participate in trials, they are often put in the same bucket [with cisgender individuals] without consideration of [their] gender identity.”

Limited transgender, nonbinary clinical trial participation data

There’s not enough data to point to trends in the participation of transgender and nonbinary people in clinical trials. Although, Paschall pointed out that only 78 (0.06%) studies in the 116,057 articles reporting clinical trial results, published between July 2018 and February 2022, stated participation of transgender patients.

Of these, most trials were focused on HIV or sexually transmitted diseases, he adds. “Either we are not asking patients, or they are not participating, and we need to understand why.”

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Parexel senior consultant of management development Liam Paschall

There are currently no blanket guidelines in the clinical trials sector with regards to the participation of transgender or nonbinary individuals. The US Food and Drug Administration (FDA) mentioned the importance of inclusion of such participants in studies in 2014 and again in 2020, but there are no guidelines yet, Paschall notes.

On ClinicalTrials.gov, there are only a handful of clinical trials that refer to transgender or nonbinary individuals in their inclusion or exclusion criteria that are not in the HIV space or investigating gender-affirming techniques. Some of these trials make a special outreach to transgender and gender nonbinary persons with “exploratory stratified analysis conducted based on both gender and sex assigned at birth”.

While some trials may welcome transgender study participants, sites are advised to “use the parameter that matches the sex assigned at birth”. There are also studies that specify that, for transgender participants who have been on hormone therapy for more than six consecutive months, haemoglobin eligibility is “based on the gender with which they identify”.

Steps to be inclusive towards transgender, nonbinary participants

Before any guidelines come into play, even “baby steps” can help boost engagement of transgender and nonbinary individuals, Paschall says. This could mean representation in marketing materials and use of gender-neutral language, he adds. Recruitment forms should go beyond asking for biological sex (male or female), but also query gender identity.

Making trial sites as friendly and inclusive as possible also helps. “We should ask and use their pronouns during consultations and have gender-neutral bathrooms at sites,” Paschall says. If a participant needs to stay overnight and share a room, asking the trans or nonbinary participant their preference on who they would be comfortable with is important, he adds. There is value in listening to patient advocacy groups to have inputs on such issues.

Long term, the clinical trials sector needs to be educated on this subject. “We need to be comfortable with being uncomfortable,” Paschall says. “If it is not patient-focused, trans and nonbinary individuals won’t see a doctor and will certainly not participate in clinical trials.”