Why LGBTQIA+ Representation in Clinical Research Matters

In the past decade, clinical research has made meaningful strides in promoting LGBTQIA+ health equity. From expanded HIV prevention strategies to the institutionalization of SOGI (sexual orientation and gender identity) data, the journey has been marked by advocacy, science, and hard-earned visibility. Yet, even amid this progress, key gaps persist. Inclusion remains fragile, and its future uncertain.

This isn’t only about data. It’s about representation, trust, and medical ethics. It’s about whose health outcomes shape tomorrow’s standards or care, and who remains visible. Inclusive clinical research benefits not only LGBTQIA+ communities but also everyone by producing more accurate, equitable, and humane science.

 

Milestones That Moved the Needle in the Last Decade

Behind each breakthrough lies tireless work from advocates, researchers, and community partners. These milestones are the building blocks for more equitable research:

• 2014 – FDA approves Truvada for PrEP, offering HIV prevention to MSM and others at risk.
• 2015 – NIH launches the Sexual & Gender Minority Research Office (SGMRO), cementing visibility at the federal level.
• 2016 – LGBTQIA+ communities are recognized as a health disparity population by NIH and NIMHD.
• 2017 – ASCO recommends SOGI data collection in cancer research protocols.
• 2018 – NIH’s “All of Us” initiative begins, prioritizing LGBTQIA+ inclusion and SOGI-integrated study designs.
• 2019 – JYNNEOS vaccine approved, later crucial during 2022’s mpox outbreak.
• 2020 – FDA shortens blood donation deferral for MSM from 12 to 3 months.
• 2021 – Injectable PrEP, Apretude, approved, eliminating daily pill stigma.
• 2022 – National Academies issue formal SOGI data collection guidelines.
• 2023 – First trans-inclusive prostate cancer trial (LIBERTAS by J&J) launches with gender-neutral design.
• 2024 – FDA hosts collaborative roundtable on embedding LGBTQIA+ inclusion in protocols and recruitment.

Despite this progress, the FDA quietly removed its public diversity trial guidance in early 2025; a move that did not go unnoticed. Advocates are now calling for formal Diversity Action Plan mandates, signaling that inclusion in research, while hard-won, remains politically vulnerable and requires continued vigilance. In response, a growing coalition of sponsors, researchers, and community partners is stepping up, pressuring policymakers to codify inclusive practices, funding research led by LGBTQIA+ scientists and advocates, calling out performative DEI efforts that lack measurable impact, and pushing for greater transparency in participant demographics and outcomes. While the future of inclusive research isn’t guaranteed, it’s being actively fought for.

 

Where Inclusion Still Lags Behind

Despite policy shifts and promising initiatives, inclusion isn’t guaranteed. In many critical areas, progress is still unraveling:

Low Enrollment Despite High Willingness

The PAN Foundation reports that 86% of LGBTQ+ adults have a positive view of clinical trials, 65% are interested in participating, yet only about 20% have ever been invited. The gap reflects systemic barriers in outreach, not community hesitation.

Curious about the root causes behind low representation in trials? Read how TFS is working to overcome structural barriers to inclusion.

Trans and Nonbinary Exclusion

Less than 1% of trials include trans or nonbinary participants. Gendered eligibility criteria and hormone therapy exclusions often disqualify them by default. This results in data that lacks real-world applicability for gender-diverse populations.

The Data Gap: SOGI Visibility Is Minimal

Approximately only 6% of oncology trials report sexual orientation and gender identity data. Even when LGBTQIA+ participants are enrolled, their identities often go unrecorded, limiting downstream care insights and perpetuating invisibility.

Explore how TFS brings precision and partnership to oncology trials, where inclusive data is more essential than ever. Learn more.

Evidence of Eagerness When Welcomed

LGB+ cancer survivors, when invited, enroll in clinical trials at over twice the rate of their heterosexual counterparts. Visibility begets engagement, but only when invitation and design are inclusive.

 

From Theory to Action: What Inclusive Trials Require

Eligibility Criteria Based on Anatomy, Not Assumption

Trials must move beyond gendered eligibility criteria to ensure that participants are judged on their relevant anatomy and medical context, rather than identity-based assumptions.

Standardized, Respectful SOGI Data Collection

SOGI data must be securely, respectfully, and consistently collected as part of standard trial protocols across studies. Skipping it undermines every effort at inclusion.

Cultural Competency for Trial Staff

Staff must be trained to support LGBTQIA+ participants. This includes pronoun usage, inclusive communication, and sensitivity to medical marginalization.

Authentic Representation in Recruitment

Recruitment materials should reflect real LGBTQIA+ lives and use language that resonates with underrepresented communities. Tokenism erodes trust; authenticity builds it.

Affirming Trial Environments

Physical space matters. From gender-neutral restrooms to inclusive signage, small changes can powerfully signal belonging or its absence.

 

The Urgency of Now: Inclusion is Not a Trend

LGBTQIA+ inclusion in clinical trials is not a favor or a PR strategy, but a fundamental pillar of scientific integrity. Invisibility in trials leads to inequity in care. And science that omits identity is science that fails to serve.

If we want a future where every identity is seen, heard, and treated, it must begin with the trials we run today. That future demands intention, and intention must be backed by structure, leadership, and accountability. LGBTQIA+ individuals are willing to participate and are vital to producing the data that will shape tomorrow’s medicine.

At TFS, we’re committed to building truly inclusive research environments, partnering with community advocates, and holding the industry to higher standards of diversity. Because this work isn’t just urgent, it’s overdue.

Looking for a partner to build more inclusive clinical trials? Let’s connect.