In the midst of this Pride Month, current politically motivated headwinds may be driving some of the terminology related to inclusive research underground, but the scientific rationale for inclusive studies is here to stay because “smart science is smart business,” says a presenter from ACRP 2025.
Addressing issues surrounding sexual gender minority (SGM) health inequities and the importance of collecting sexual orientation and gender identity (SOGI) data during clinical trials, Meghan McKenzie, MA, Director of Health Equity and Clinical Research with the Inclusion and Belonging Office for Genentech, notes that SGM individuals have significant health impact differences from others, including increased incidence of some cancers and other conditions due to their social drivers of health.
“It’s up to us to create a safe space for our patients,” and that effort is built on an understanding of their life situations, McKenzie says. “If you don’t collect optional, self-reported SOGI data—and this information hasn’t historically been collected in studies—you cannot understand if there is a lack of representation in your trials, the access gaps to them, or differences in health outcomes,” she adds.
McKenzie points to a Sexual Orientation and Gender Identity tool from the Clinical Data Interchange Standards Consortium (CDISC) as a valuable resource for helping researchers working in trials to better understand and use recommended SOGI terms. The National Institutes of Health and the Institute of Medicine both advise that collecting SOGI data in clinical trials and electronic health records is best practice, she adds.
According to information introducing the CDISC tool, “Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual/Aromantic, and all sexually and gender diverse (LGBTQIA+) people are at a greater risk for mental health, cardiovascular, infectious, cancer, and other chronic illnesses due to historical discrimination and marginalization. …[T]here is a lack of the necessary information to study the effects of health treatments and interventions for the LGBTQIA+ population. The [SOGI tool] aims to promote health equity by capturing this missing information.”
The ACRP 2025 session on “Clinical Trial Diversity and Intersectionality: Looking at the Whole Patient,” also featured insights from Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard; Behtash Bahador, Director of Health Literacy, Center for Information and Study on Clinical Research Participation (CISCRP); and Fenwick Eckhardt, Head of Diversity Strategy, Citeline.
Other resources pointed to by the panelists included:
The Diversity Convergence Project: Toward a National Action Plan for Achieving Diversity in Clinical Trials from the MRCT Center, the Milken Institute, and the Clinical Trials Transformation Initiative
MRCT Center Model Diversity Action Plan
The MRCT Center Clinical Research Glossary
Project Equity on diversity action plans in oncology from the U.S. Food and Drug Administration’s Oncology Center of Excellence
Professional Services available to researchers from CISCRP
Meanwhile, various other clinical research study and site management–related topics were also in focus during sessions presented at the ACRP 2025 gathering in New Orleans in April. A package of collected recordings of these sessions is now available for purchase in the ACRP Course Catalog, as are packages for the full program of ACRP 2025 replays or smaller packages themed on Workforce Development, Regulatory & Compliance, Clinical Trial Design, Leadership & Professionalism, and Technology & Future Trends. Conference attendees already have access to all recorded ACRP 2025 sessions that correspond to their conference registration type (Full, Weekend, or One-Day Registration) by logging onto the ACRP website and visiting their My Courses Dashboard.
Edited by Gary Cramer
