Making Clinical Trials More Inclusive for Sex- and Gender-Diverse People
Chloe Stephenson, Research & Insights Manager at COUCH Health, shares pharma industry key learnings and actions generated from conversations with sex and gender-diverse patients to create more inclusive clinical research environments.
Can you explain what we mean when we discuss “sex and gender diversity” in clinical trials?
Sex and gender diversity means moving away from the binary model and embracing a more inclusive approach. Particularly in healthcare, gender is often incorrectly equated with biological sex assigned at birth and thought of in binary terms as being “male” or “female”. But biological sex itself is not a binary concept, because it includes people who are intersex. There is so much diversity even within intersex people, highlighting the complexity and variation in sex and gender identities beyond the traditional binary model.
At COUCH, we know that there is not enough representation of LGBTQIA+ and gender-diverse people within healthcare in general. Our mission with COUCH Conversations was to understand the lived experiences of people directly impacted to help improve representation and inclusivity of sex and gender-diverse people in both healthcare and clinical trials.
What do LGBTQ+ patients typically fear in healthcare settings?
Many LGBTQIA+ patients usually expect, experience, and/or anticipate that they might be misgendered, discriminated against, or even outed during their appointments. This leads to many people avoiding healthcare settings altogether – leading to later diagnoses, poorer health outcomes and less participation in clinical trials. If people are afraid to even go to their doctor for fear of discrimination, how can we expect someone to sign up for a clinical trial?
However, the issue extends beyond patient experiences. Our research into eligibility criteria and inclusion/exclusion language revealed that some trials exclude many people within the LGBTQIA+ community, including trans, non-binary people, and people in same-sex relationships. For example, in a study of 243 clinical trials related to couples and sexual function, 37 trials explicitly excluded people in same-sex relationships. There is almost no reason why they should have been excluded, but systemic implicit bias feeds into that. We’re trying to put an end to these exclusions, or if there is a perceived necessity, to understand the rationale behind such exclusions thoroughly.
"There is so much diversity even within intersex people, highlighting the complexity and variation in sex and gender identities beyond the traditional binary model."
What key learnings can you share with the pharma industry?
First: training alone is not a fix for the issue of inclusion. However, astonishingly, we found from speaking to healthcare practitioners and people working in the industry that inclusivity training is often not even implemented in everyday practice.
Second: we found that there was a lot of awkwardness from healthcare practitioners across industries around how to approach people whose gender expression is different from their sex assigned at birth.
Third: when it comes to typically gendered conditions, there was a lot of uncertainty from healthcare practitioners around navigating uncomfortable conversations. For example, if there were a clinical trial for breast cancer, many clinicians or site staff would not know how to approach the situation if a trans man were a patient.
Fourth: a big barrier for LGBTQIA+ people is fear of accessing healthcare. You can ease fears by signposting to the relevant gender clinics or to site staff who are gender-inclusive and have that specific training/knowledge – which, in theory, should be all site staff.
Fifth: the overarching theme is that tackling these systemic issues often hinges on small actions. Approaching situations with empathy, care, and curiosity reminds us that we’re all humans and helps remove the “us versus them” mentality that can prevent productive conversations.
What can be done to ensure that training leads to more inclusive environments?
The most successful trainings were interactive, in-person and involved workshopping rather than doing an online course.
In the past, we’ve bridged the gap between patients, researchers and healthcare practitioners by asking people with lived experience to collaborate with us by giving talks, presentations or workshops. That makes it an immersive, workshop-like approach, as well as patient-first, that begins to break down the barriers. Our actionable guide for HCPs on sex and gender diversity launches in June and breaks down the 3 steps to inclusive training: make it memorable, make it relevant and make it a requirement.
"A big barrier for LGBTQIA+ people is fear of accessing healthcare. You can ease fears by signposting to the relevant gender clinics or to site staff who are gender-inclusive and have that specific training/knowledge."
You also spoke to industry folks for your research. What did they have to say?
There was an openness and awareness that we need to do better. They felt as though they were in a bit of an echo chamber; they know that our forms should be more inclusive, for example, but there still isn’t a standardized approach to doing so.
How can we begin to get out of the “echo chamber” and make inclusivity a more company-wide priority?
If you can standardize forms to be more inclusive (for example, including more than two genders, asking separate questions for sex and gender), it becomes the norm for procedures from the get-go. Then, instead of the story going, “We need to include more trans people in our trial, let’s use this form”, and inclusivity being an afterthought, everything is standardized to be inclusive from the beginning.
Inclusivity works for us all. By improving accessibility and inclusiveness, we help not just one particular population; we help everyone. In pharma, there is a lot of red tape and processes to navigate. But if we can include inclusivity and accessibility in the very early stages of design and development through simple things like removing gendered language, it helps everyone across the board.
Why is this so important for the pharma industry to focus on?
When it comes to collecting data around sex and gender, it’s essential to see the patient as a whole, holistic person. Yes, you do need to understand the biological model – such as sex assigned at birth and how a drug interacts with that. But, equating sex with gender leads to misinterpretations and biases. For example, it’s often incorrectly assumed that a trans man or trans woman can’t get breast cancer or ovarian cancer, when in some cases the rates are actually higher. Rethinking our approach to sex and gender diversity can ultimately lead to better health outcomes for everybody.
In the example of that trans male patient, they may have female hormones, but they identify and live as a man. It’s important to consider the entire individual to understand both the scientific and personal impacts. Because if we say, “We want to talk to pregnant women for this study,” a trans man might wonder, “Well, does that include me? Is that me?”. Inclusivity with our language, our forms and our processes ensures that we connect with sex and gender-diverse people while capturing the data we need, to be certain of the scientific rigor.
What immediate actions can the pharma industry take to cultivate a more inclusive environment?
We need to begin with open conversations, leading with empathy, curiosity, and compassion, to override our implicit biases in how we think about sex and gender. We are releasing some actionable guides for healthcare practitioners, LGBTQIA+ people and allies, which coincide with our research. These guides include terminology and “Don’t say this, say that instead” guidance to overcome the fear of saying the wrong thing. We have to start somewhere because the fear of doing something wrong is holding us back from making real progress in inclusivity.
One easy thing to focus on is creating inclusive forms. It shouldn’t be: “male, female, other” for instance. We are trying to move away from the term “Other;” and consider alternatives like “Alternative identity” and open text boxes. It's a small change, but it can make a huge difference. Additionally, finding ways to ask for people’s pronouns is another way to be inclusive and not assume someone’s gender.
Another important step is increasing visible signs of allyship. As I mentioned earlier, small actions can help address these bigger systemic issues. Introducing your pronouns is a simple yet effective way to show your support if you don’t have the budget for lanyards, pins, or posters. These small gestures make a difference in showing LGBTQIA+ people that they are welcome in a space.
"Inclusivity works for us all. By improving accessibility and inclusiveness, we help not just one particular population; we help everyone."
What are longer-term goals that we can set?
The first long-term goal is to ensure that the training we provide is not tokenistic but actionable and implementable.
We must also ensure that we have diversity among site staff, including more people of color, queer people and gender-diverse people, along with intersections of all those. We constantly hear from patients, “No one looks like me,” or “That trial is not for me.” So, whether it's on your actual site or in your communications for trial recruitment, make sure you represent the community you’re trying to serve.
And finally, the ultimate goal is to rebuild trust. We can do that through all of the outlined actions above, as well as through accountability and community outreach efforts that reach people from diverse populations. Education and training are key to making this happen.
You can sign up to the Demand Diversity mailing list on the website to be the first to know when our ‘How-To’ guide for healthcare professionals, developed in collaboration with the LGBTQIA+ community, is available for download.
