We Don’t Know What We Don’t Know: LGBTQIA+ Patient Data and the Struggle for Inclusivity

Opening SCOPE 2024 on Sunday, Fareed Melhem, senior vice president and head of Medidata AI at Medidata Solutions, Inc., set the conference’s theme by stating, “It’s important for patients to think about trial research as just one piece of their overall care.”

The patient journey is taking center stage so far in 2024. Throughout the drug development and commercialization stages, the patient is the focus. Considering the patient journey is critical for accurate data collection in clinical trials and for the success of AI in drug development.

This overall theme was repeated by Katherine Taylor, head of risk evaluation & adaptive integrated monitoring at Merck & Co. who moderated a panel discussion focused on integrating research into the care continuum. “There is ample opportunity to normalize participation for all patients through the convergence of clinical research and clinical care,” Taylor said.

And so, SCOPE kicked off with Melhem’s vision for improving the experiences of diverse patients throughout their care journeys and concluded with back-to-back panel discussions on how the biopharma industry is working to include sexual and gender minority (SGM) patients.

Led by the SGM Alliance, the two panels included representatives from drug developers, including Amgen, AbbVie, Johnson & Johnson, GSK Bio, Pfizer and Eli Lilly and Company, as well as CRO PPD. The first panel, Inclusivity for the LGBTQIA+ Community: Count Me In, focused on the challenges LGBTQIA+ patients face.

Personal stories from the panelists highlighted biases not only in clinical trial protocols and language but on the part of healthcare providers. Amanda Beasley, Representation in Clinical Research (RISE) director at Amgen, spoke candidly about the frustration her spouse has experienced dealing with healthcare providers, citing an endocrinologist who misgendered him multiple times and did not use his preferred name despite having this information. Similar experiences were echoed by other panelists.

Solomon Yakubov, associate director, site engagement, global clinical operations at GSK, said looking for healthcare providers aware of the unique needs of sexual and gender minorities is an uphill battle even in larger cities. “Patients often have to bring healthcare needs and standard of care to their practitioners instead of the other way.” He further added that the patient battle goes deeper into testing and expands to multiple sites.

It is this type of traumatic patient journey that Garo Kiledjian, founder and CEO of SGM Alliance, said leads to mistrust of the healthcare system and the pharmaceutical industry. In an interview with BioSpace, Kiledjian said the discussion truly started a year ago when he was a panelist on an open roundtable at another conference. He explained the challenges he faced in running clinical trials for LGBTQIA+ patients and in securing his own care, as a gay man. That discussion has since created a ripple effect within the industry. “We have been talking about race and ethnicity since the pandemic, but this was the first time we were focusing on sexual and gender minorities,” Kiledjian said.

And this discussion is needed. The National Institute on Minority Health and Disparities (NIMHD) reported that there has been a steady increase in those who identify as part of the LGBTQIA+ community: 4.2% of Generation X (1965 – 1980), 10.5% of Millennials (1981 – 1996) and 20.8% of Generation Z (1997 – 2003).

The Food and Drug Administration (FDA) is also aware of the need to include this population in clinical trials. Kiledjian shared, “The FDA is now making multiple requests for sexual orientation and gender identity (SOGI) data collection. As we have seen in the past, these requests tend to foreshadow what will become requirements in the future.”

He has seen a shift in the industry toward wanting to learn how to include LGBTQIA+ data. As of SCOPE 2024, which took place February 11 to 14, SGM Alliance has partnered with more than 25 pharmaceutical companies, CROs and technology solution providers, as well as collaborating with government entities.

The mindset needs to change, and this will only come through talking about LGBTQIA+ inclusion with all industry stakeholders. Moderated by SGM Alliance Chief Research Officer Jessica Brescher, the second panel discussion, Overcoming Access Barriers to Healthcare for the LGBTQIA+ Community: Bridging Gaps, Driving Change, highlighted ways to increase diversity and representation in clinical trials, emphasizing the need for granular data collection, inclusive language and cultural appropriateness. SCOPE organizers selected the panelists from Eli Lilly, Pfizer, Johnson & Johnson, GSK and AbbVie because these companies are actively pursuing ways to be inclusive in clinical trials.

The conversation is ongoing and mistakes will be made. Denise Johnson Sura, who serves as associate vice president, design hub foundations at Eli Lilly and is accountable for recruitment and retention and diversity and inclusion in clinical trials, shared how she educated herself on how to be more inclusive. “It was a year-long journey that basically helped me understand how to be more comfortable and competent . . . just using language [and] not being afraid to being open to learn,” she said. Lessons learned pertain to partnering with trial sites, data collection strategies and protocol changes, such as inclusive language.

Sandra Amaro, head of clinical trial diversity at Pfizer, shared that the company is a sponsor of the Human Rights Campaign, which is connected to the Healthcare Equity Index (HEI). The HEI is the national LGBTQIA+ benchmarking tool, designed to evaluate healthcare facilities’ policies and practices of equity and inclusion for LGBTQIA+ patients, visitors and employees. While prefacing that she was there to learn and take back key points on how to better serve the LGBTQIA+ patient community, Amaro directly addressed the sponsors and sites in the room during the discussion, encouraging them to leverage the HEI data when selecting trial sites.

Michel Reid, senior director and head of global demographics and diversity at GSK, added that communication and education are vital, especially for sites and healthcare providers. The industry is learning how to collect data in ways that are approachable and accessible, he said but recognizes that it is not there yet. “We don’t have the right data capture. We want this [LGBTQIA+] participant in our study, but there are some issues on how to respect that person and also manage the science.” He emphasized that while that conversation is still evolving, the industry’s communication channels are open and welcoming, and span globally.

Shir Netanel, associate director of patient advocacy and clinical trial advocacy, global medical affairs oncology at Johnson & Johnson Innovative Medicine, explained that the company is working on creating inclusive clinical trials with appropriate language and protocols. Johnson & Johnson is running one of the first de-gender and trans-inclusive prostate cancer clinical studies in which eligibility is determined solely by the patient’s disease. “The protocol is gender neutral and defines eligibility based on disease criteria, not sex or gender,” Netanel shared. This study is also collecting SOGI data in the United States. The LIBERTAS study opens the clinical trial to transgender patients, who are often excluded from prostate cancer trials and serves as a foundational model for SGM inclusion in clinical research.

Data are, and will always be, a hot topic as the pharmaceutical industry relies on accurate information, particularly now with the increased adoption of AI. The industry is evolving to be more inclusive in order to generate data that captures a complete representation of patient populations. As LGBTQIA+ identification increases, these data become even more important.

When asked about the future, Kiledjian said he feels that companies should start preparing now by working to include LGBTQIA+ patient populations. “With the increase of individuals self-identifying as part of the LGBTQIA+ community combined with the FDA’s increased for SOGI data, companies creating inclusive protocols now will be more prepared for the future.’

Legal Disclaimers: The panels had representatives here today from AbbVie, Amgen, GSK, Johnson & Johnson, and PPD. The thoughts they share on this panel are their own and do not reflect their companies’ views on any of the topics. Please note that the panelists do not exclusively represent the full breadth and diversity within the SGM community, as each identity and experience within the community is unique to each individual. We would also like to acknowledge the privileges shared across this panel as it relates to their education, health literacy, and access to healthcare.

Lori Ellis is the head of insights at BioSpace. She analyzes and comments on industry trends for BioSpace and clients. Her current focus is on the ever-evolving impact of technology on the pharmaceutical industry. You can reach her at lori.ellis@biospace.com. Follow her on LinkedIn.