Diversity in Clinical Trials: LGBTQIA+ Community Needs Not Just Allies, but Crusaders

The US Food and Drug Administration (FDA) updated its guidance on clinical trial Diversity Action Plans in June. But the collection of sexual orientation and gender identity (SOGI) data is not mandated. See what industry experts say can be done to improve LGBTQIA+ representation in clinical research.

Diversity in clinical trials encompasses more than simply including participants of underrepresented racial and ethnic populations. True diversity also takes into account gender identity, age, disability, and other demographics.

Expanding the definition of — and regulations around — diversity in research has been on the radar at the US Food and Drug Administration (FDA) since it issued draft guidance in April 2022. The purpose of this guidance, explains Citeline Head of Diversity Strategy Fenwick Eckhardt (she/her), was to increase enrollment of those historically underrepresented in clinical trials, in order to improve the strength and the generalizability of the evidence for these populations. Included in the guidance were recommendations on the submission of Diversity Action Plans for certain clinical studies.

Fenwick Eckhardt

When the Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law in December of that year, the FDA took those plans beyond race and ethnicity to include enrollment by age group, sex, and non-demographic characteristics. In November 2023, the FDA held a two-day workshop on the plans, releasing updated guidance on the collection of race and ethnicity data in clinical trials in January of this year. But more recently, and where all the buzz has been, Eckhardt said, is the FDA’s June 2025 revised guidance on diversity action plans.

“The draft acknowledges the FDA's recognition of this broader issue regarding health disparities and the differential access to healthcare and clinical studies based on other factors,” Eckhardt said. “And it does specifically call out gender identity, sexual orientation, geographic location, socioeconomic status, physical and mental disabilities, pregnancy status, lactation status, and also comorbidities. But the collection of sexual orientation and gender identity, or the SOGI data, is not mandated.”

Eckhardt was joined on an Association of Clinical Research Professionals (ACRP) webinar, “Deepening Diversity: LGBTQIA+ Diversity in Clinical Research,” by Shir Netanel, (she/her), Associate Director, Patient Advocacy and Clinical Trial Advocacy, Global Medical Affairs Oncology, Johnson & Johnson; Garo Kiledjian (he/him), Founder and CEO, SGM Alliance; and transgender health advocate Liam Paschall (he/him), Founder and Director of Liam Paschall Consulting and Global Enablement Manager, Global Sales Onboarding at Adobe.

Liam Paschall

Paschall was blunt about the FDA’s lack of direction when it comes to LGBTQIA+ diversity in research: “We don't have really any guidance from the FDA at all, and this is something that we really would like to see change. … No guidance means no true standards at all.”

He provided a laundry list of challenges associated with trial diversity, noting that these challenges apply not only to the trans community, but to the greater LGBTQIA+ community and other marginalized groups as well. A few key challenges include:

• Limited access and representation
• Lack of targeted recruitment strategies
• Barriers to participation including bias, stigmatization, logistics, and privacy

So how can sponsors address these challenges? “Data collection is a huge, huge place for an opportunity,” Paschall said. Communication is another area in need of improvement. “One-size-fits-all approaches just don't cut it.”

Location is a major concern, he added. “If someone from the LGBTQ+ community is in an area that has introduced anti-LGBTQIA+ legislation, people in our community are terrified. Combine that with the fact that many in the community are underemployed or unemployed and they may live on the outskirts in the rural areas. We are increasingly left out [of trials] for those reasons.” 

Paschall said informed consent needs an overhaul. “We need to see more than just male and female. There's no roadmap for us. We don't have those trans-specific protocols. We're not asking for a lot here. We're asking for basic inclusion, understanding, and respect. And it's really time for the medical and clinical communities to step up to get educated, to get trained and start treating us like we matter because our lives literally depend on it.”

He said overcoming these challenges requires a multifaceted approach, including:

• Recognition of intersectionality of identities
• Foundational training for all staff on transgender cultural competence and sensitivity
• Policy and advocacy
• Community outreach, engagement, and collaboration
• Accessible and beneficial dissemination of findings
• Pronouns and chosen name usage
• Gender-neutral restrooms and facilities

Shir Netanel

J&J’s Netanel shared some statistics: “To date, 11 million self-identified LGBTQIA+ people currently live in the United States. And this number is increasing rapidly.” According to a report by PRRI¹, a nonprofit that conducts research on religion, values, and public policy, 28% of Gen Z identifies as LGBTQ. Yet, Netanel noted, there are still significant health disparities in this community that are not being addressed.

“What we are doing at J&J to address this,” she said, “is we have an ongoing Phase III study called the LIBERTAS study, which is one of the first degendered and trans-inclusive study protocols on prostate cancer. And this study serves as a foundational model for LGBTQIA+ inclusion in clinical studies. LIBERTAS widens the pathway for representation of transgender and nonbinary communities in prostate cancer, which is a disease that has not traditionally included this underserved patient population.”

J&J has employed gender-neutral language throughout the protocol and informed consent, which will broaden the eligibility criteria. Netanel said the inclusive and degendered protocol language applied to LIBERTAS is being adopted across all of J&J’s oncology therapeutic areas studies. “We are actively enabling the therapeutic areas to also degender their clinical study protocols,” she added.

She said J&J also is implementing the collection of SOGI data. In addition, J&J is providing culturally inclusive LGBTQIA+ training for its study sites and internal teams. “This is a cultural shift,” Netanel said, ”to be able to get to a point in which we are creating affirming spaces for LGBTQIA+ people. And this is an essential step in building trust with the community. I think that for recruitment and retention, if we're not affirming patients, we're using their dead names, we're misgendering them, these are going to make patients stop coming back to the study. So it's important to get them in the door through these inclusive measures in our study design, but it's also equally as important to retain these individuals.”

Netanel cautioned that collecting SOGI data must be done with deliberate care and in a way that does not offend LGBTQIA+ patients. To that end, J&J is working with Fenway Health to develop a toolkit that provides this culturally sensitive training for HCPs and site staff who will be interacting with LGBTQIA+ patients. J&J is creating an e-learning module to accompany the toolkit, with the goal of making it an open-source, widely accessible tool.

Paschall encouraged sponsors to work with LGBTQIA+ advocacy groups to promote representation in clinical trials. That is the mission of SGM Alliance, which educates and advocates for inclusive, sexual, and gender minority participation in clinical research, life sciences, and the evolution of healthcare. Founder Kiledjian said 15 companies are on board, and that representatives from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) sit on the SGM Alliance board.

Collaboration is a good start, but Paschall says more voices are needed. “It really is going to take people not just being allies, but almost being crusaders and standing up … and educating people.”

Garo Kiledjian

Kiledjian explained that SGM stands for sexual and gender minorities, adding that SGM is more inclusive than LGBTQIA+ because it includes all sexualities and all genders. SGM Alliance coordinates its efforts for inclusion around three pillars: protocol design/language in clinical studies, data collection, and education. It has created six work streams: protocol design, data collection, patients with HIV, transgender patients, site education, and sponsor and CRO education.

“We're creating change and noise in the industry and combating discrimination because it is not borderline discrimination. It is discrimination.

“There's a blind copy and paste that's happening in the industry where language from the ’90s is being blindly copied and pasted into protocols,” Kiledjian said. “So what we're advocating for is for it to be scientifically justified.” When a protocol excludes folks on HIV medication, for example, he said not only are HIV-positive folks being excluded, but HIV-negative folks are being excluded as well because of PrEP. 

“We are really advocating for us to do better as an industry,” Kiledjian said. “Can we do better? And the answer to that question is yes.”