“It’s hard to make decisions without data,” says Lorena Kuri, head of diversity strategy for Bristol-Myers Squibb (BMS), lamenting the lack of LGBTQ+ patients in clinical trials. She calls on clinical trial practitioners to include sections in documents where participants can self-identify by gender, sexuality, and other factors to help “make the clinical trial journey as safe” and effective as possible.
The lack of data and the absence of any significant registries or other repository of demographic knowledge continues to hinder clinical trials for those in the LBGTQ+ community, Kuri says. “This is going to require multi-sponsor cooperation,” she adds.
Kuri says she took heart in the U.S. Food and Drug Administration’s (FDA’s) guidance on diversity, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry,” issued in April by the agency.
“It was great to see the FDA calling for diversity plans” to include data and focus beyond race and ethnicity, Kuri says. “It’s a huge win for patients” and hopefully will inspire increased data collection for those in the LGBTQ+ community, especially when it impacts a drug designed to include that population, she says.
Further, while the COVID-19 pandemic highlighted disparities in healthcare in terms of access and other issues, BMS was already serious about promoting diversity in trials, Kuri says. “We take a process-driven approach that draws on our own diverse culture,” she notes. “If our objective [as an industry] is to develop trials with populations that reflect the real world, we must include everyone—it’s a moral and scientific imperative,” she adds.
Author: Michael Causey