ARE YOU READY TO INCLUDE THE SEX AND GENDER MINORITY COMMUNITY IN YOUR CLINICAL STUDY?

Diversity in clinical studies is becoming a much bigger conversation

In terms of diversity in research, the wind is shifting; the voices of the sex and gender minority (SGM) community—including their needs and barriers—are being uncovered. This community is moving away from being forgotten, deprioritized, and perceived as too difficult to capture in the data, to one whose presence is needed and undeniable. While there is growing acceptance of the need for better representation, understanding and addressing the needs of this community without bias remain areas in which significant work is still required.

Inclusive language, or a lack thereof, perpetuates medical mistrust

There are countless stories about individuals from the SGM community being mistreated and mismanaged by the healthcare system. Stories about healthcare professionals who handle patients with excessive precautions, refuse to touch them, or outright refuse to provide care. As a result, many SGM patients do not divulge their gender or sexual identity out of fear that it will impact the care that they receive; many delay or avoid seeking care altogether.

Outside of clinical studies in mental health, sexually transmitted diseases, or gender-affirming care, few studies mention SGMs in their eligibility criteria. It is interesting to see this perpetuated on ClinicalTrials.gov in the advanced search filters under Eligibility Criteria; studies can be filtered by “Sex” with the only options listed being “All,” “Female,” and “Male.” This limited definition often extends to intake, demographic, and medical history forms, ultimately categorizing SGM patients and participants by their sex assigned at birth without considering their gender identity.

Inclusive language and imagery are powerful tools that acknowledge diversity and convey respect. They can mean the difference between someone feeling safe and welcome, or feeling fearful of prejudice for reasons inherent to their identity.

In the realm of clinical studies, simple modifications to study documents and language can indicate that individuals who are part of the SGM community are welcome to participate and will not be grouped based solely on a binary definition of sex or gender. This is equally important when analyzing and reporting data.

So, what would create or indicate a safe and welcoming environment to this community? This is where the power of communication is vital.

  • A clinic waiting room can provide plenty of clues regarding its climate and culture for visitors and patients—predominantly displayed non-discrimination policies, pride symbolism, and diverse posters and literature are simple resources that convey welcome for members of the SGM community
  • Help ease concerns around how patients represent themselves by asking patients for their pronouns and how they would like to be addressed
  • Reinforce respect and inclusivity by avoiding the use of traditional gendered terms like Sir or Ma’am, and instead address patients by their preferred name
  • Reduce anxiety by creating space on intake forms for preferred pronouns and/or gender identification, and by using inclusive language in eligibility criteria, demographic, and medical history forms
  • When possible, stratify and present findings based on sex assigned at birth and gender identity; this has been supported in the recently released Journal of the American Medical Association (JAMA) guidance on reporting gender, sex, gender identity, sexual orientation, and age in medical and scientific publication1

There are opportunities to facilitate inclusive clinical research, emphasize respect, and make clinical studies a welcome and safe space for all. Language holds power, and that is where we step in.

Are you ready to redefine representation in your clinical trial?

We invite you to join us as we explore the stories of underrepresented patient groups. Their stories will close gaps in knowledge, uncover barriers to participation, and inform strategies to create equitable and accessible studies as we strive to ignite change and redefine clinical study representation. Stay tuned…

Neurodiversity—not only is there a need for a greater number of studies for the neurodivergent community, but also for inclusion in studies in other therapeutic areas. Join us as we are guided through a discussion on neurodivergence and are encouraged to reconsider inclusion from a perspective that is not “neurotypical.”

Cultural and religious beliefs—cultural mosaic or melting pot: which best describes how cultural differences and religious beliefs are viewed and managed in clinical research? Join us as we explore how one’s background, faith, and religious practices drive perceptions, acceptance, and actions toward clinical trials as a treatment option.

Digital equity—regardless of socioeconomic status, all should have equal access to modern digital technology, the internet, and digital literacy training. It ensures that everyone can fully participate in the digital world, including having the skills and resources necessary to use digital technology effectively. This is crucial in today’s world where much of education, work, and communication happens online.

REFERENCES

  1. Flannigan A et al. Draft Guidance on Reporting Gender, Sex, Gender Identity, Sexual Orientation, and Age in Medical and Scientific Publication. JAMA 2024;332:e2416646. doi:10.1001/jama.2024.16646.