#TalkClinicalTrials: Calling all allies!

In this #TalkClinicalTrials blog, Kim Meeking, Co-lead Queering Cancer explores why 2SLGBTQ+ inclusion in clinical trials must go beyond intention—embedding allyship into every step of the research process. From addressing bias to redesigning eligibility criteria, Kim outlines how clinical trials can become more inclusive, accessible, and affirming for everyone.

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Everyone can be an ally. Whether you are just starting to learn 2SLGBTQ+ inclusion, wanting to deepen your awareness, or part of the community yourself and wanting to support others, you have a vital role to play. The anti-oppression network defines allyship as:

“an active, consistent, and arduous practice of unlearning and re-evaluating, in which a person in a position of privilege and power seeks to operate in solidarity with a marginalized group.”¹

Allyship in research is about being willing to learn, adapt, and take action. It’s about noticing the ways our systems fall short and actively working to make them more inclusive, accessible, and effective, for everyone. Canada is home to approximately 1.4 million 2SLGBTQ+ people, including nearly 60,000 transgender and nonbinary individuals.² This is a growing demographic, with younger generations increasingly identifying as something other than straight or cisgender. As this population ages, it’s inevitable that more 2SLGBTQ+ people will become eligible to participate in clinical trials.

Our communities face a long history of discrimination and mistreatment by the medical establishment. And you don’t have to look far back—until 2019, the World Health Organization still classified being transgender as a mental disorder, and conversion therapy was only banned in Canada in 2021. ^{3 4}

Belonging to a marginalized group is associated with something called minority stress, a form of chronic stress stemming from historical stigma, prejudice, and everyday discrimination. This contributes to a range of health disparities: higher rates of poverty and unemployment, increased smoking and alcohol use, lower access to healthcare, and poorer mental health. 2SLGBTQ+ communities also face elevated risks for certain cancers and long-term health conditions.

How Does This Relate to Clinical Trials?

Sex, gender, and sexual orientation can influence disease risk, how illness presents, and how individuals respond to treatment—but we don’t yet fully understand the scope of these influences. One major reason is that clinical trials have historically failed to collect or report data on sexual orientation and gender identity.

In fact, of over 116,000 published clinical trials, only 78 explicitly noted the participation of transgender patients—and most of those were focused on HIV or STIs. ⁵ We also see explicit exclusion: among 243 trials related to couples and sexual function, 37 deliberately excluded people in same-sex relationships. ⁶

Language in trial materials can also unintentionally exclude 2SLGBTQ+ people. For instance, inclusion criteria like “women of childbearing potential must use contraception” may exclude lesbians or bisexual women in same-sex relationships. Not all women have sex with people who can make them pregnant—but if they’re not using contraception, they may still be excluded due to rigid, outdated language.

What’s discussed less often is how implicit bias contributes to the underrepresentation of 2SLGBTQ+ people in research. When we talk about bias in clinical trials, we often focus on things like selection bias or reporting bias. But some of the most enduring biases are subtle, unconscious, and built into the systems and assumptions that shape trial protocols.

There is an implicit (unconscious) preference among heterosexual healthcare providers towards heterosexual patients ⁷. This affects patient-provider interactions, and might result in a reluctance to engage with 2SLGBTQ+ patients, or making snap judgements about their eligibility or willingness to participate. Whether intentional or not, the impact is the same: exclusion, invisibility, and harm.

When 2SLGBTQ+ people are absent from research, it distorts health data and limits our understanding of health outcomes across diverse populations.

This is where allyship comes in. Allyship in clinical trials starts with intentional awareness. A meaningful first step is acknowledging the systemic issues 2SLGBTQ+ people face. Recognize that mistrust of the healthcare and research systems is rooted in real histories of harm. Then, take steps to change the structures that reinforce exclusion. Inclusive trials not only produce better data, but they also lead to better science and more equitable care.

Start by examining the structural biases built into study designs and materials, as well as your own assumptions. Review eligibility criteria that may unnecessarily exclude 2SLGBTQ+ participants—such as binary gender categories or assumptions about sexual activity. Audit your policies and language for exclusionary or gendered phrasing. Ask yourself: Who might be left out? Then take steps to change those patterns.

To explore your own unconscious bias, try tools like Project Implicit, and refresh your understanding of sex and gender through resources like the Government of Canada’s Gender-Based Analysis+ course.

Communicate Inclusively

Inclusive communication starts with language. Avoid making assumptions about someone’s gender, sexual orientation, relationships, or body parts. Use gender-neutral alternatives—for example, “patient,” “person,” “partner,” or “spouse” instead of “man,” “woman,” “husband,” or “wife.” Replace “his/her” with “their” (e.g., “They are here for their appointment.”)

Whilst you might not have the option to change how eligibility criteria is written in a protocol, you can adapt the language you use in conversation with colleagues and participants to make sure you are being inclusive. Those everyday choices can make research environments significantly more welcoming and affirming.

Inclusion Takes Effort—Not Perfection

Being an ally in clinical trials isn’t about getting everything right—it’s about staying committed. It means actively noticing where our systems fall short, and choosing to do better. It means using your position to help ensure that 2SLGBTQ+ individuals are seen, respected, and included in the science that shapes their care.

For more information on fostering inclusion in clinical trials for 2SLGBTQ+ participants please visit (and bookmark!) these two great resources:

• Equity, Diversity and Inclusion Framework and Toolkit developed by The Canadian Cancer Clinical Trials Network.
• LGBTQI+ Inclusion By Design in Clinical Research Toolkit developed by the Multi Regional Clinical Trials Centre of Brigham and Women’s Hospital and Harvard.

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Source

1. The Anti-Oppression Network. (n.d.). Allyship. https://theantioppressionnetwork.com/allyship/ ↩︎
2. Statistics Canada. (2022). Age, sex at birth and gender reference guide: Census of population, 2021. https://publications.gc.ca/collections/collection_2022/statcan/98-500-x/98-500-x2021014-eng.pdf ↩︎
3. World Health Organization. (2019, May 17). Moving one step closer to better health and rights for transgender people. ↩︎
4. Government of Canada, Department of Justice Canada. (2021, November 29). Government introduces legislation to ban conversion therapy practices in Canada. https://www.canada.ca/en/department-justice/news/2021/11/government-introduces-legislation-to-ban-conversion-therapy-practices-in-canada.html ↩︎
5. Ludmir, E. B., Espinoza, A. F., Jethanandani, A., et al. (2020). Reporting and exclusion of sexual and gender minorities in cancer clinical trials. International Journal of Cancer, 146(8), 2360–2361. https://doi.org/10.1002/ijc.32700 ↩︎
6. Egleston, B., Dunbarack, R., & Hall, M. (2010). Clinical trials that explicitly exclude gay and lesbian patients. The New England Journal of Medicine. https://doi.org/10.1056/NEJMc0912600 ↩︎
7. Casanova-Perez, R., Apodaca, C., Bascom, E., Mohanraj, D., Lane, C., Vidyarthi, D., Beneteau, E., Sabin, J., Pratt, W., Weibel, N., & Hartzler, A. L. (2022). Broken down by bias: Healthcare biases experienced by BIPOC and LGBTQ+ patients. AMIA Annual Symposium Proceedings, 2021, 275–284. https://pubmed.ncbi.nlm.nih.gov/35308990/ ↩︎