The pharmaceutical industry is poised to maintain its commitment to diverse clinical trial enrollment despite recent political developments that have led to the removal of federal diversity, equity, and inclusion (DEI) resources. Industry experts emphasize that the scientific rationale for diverse trial populations remains compelling, regardless of policy changes.
Industry Response to Policy Shifts
Following a recent executive order to end "radical and wasteful" government DEI programs, several key resources on diversity in clinical trials were removed from the US Food and Drug Administration (FDA) and National Institute of Health (NIH) websites. While some pages have been restored, several important guidance documents remain inaccessible, including those related to sex- and gender-specific research.
Jackie Kent, a pharmaceutical executive with nearly 30 years of experience and director at Jumo Health, emphasizes that the industry's commitment to inclusive research predates recent regulatory guidance. "We have been working on diversity – or as I call it, inclusive clinical research because it's not just about race – it's race, religion, gender, sexuality and disabilities – for five years," Kent explains.
Scientific Justification Drives Continued Progress
The push for diverse trial populations is fundamentally rooted in scientific necessity rather than political considerations. Kent notes that the industry's focus stems from the need to study diseases in populations that reflect their actual prevalence, ensuring more rigorous and representative clinical research.
"I do not think pharma is going to want to change that focus," Kent states. "Legislation makes it easier and more consistent, but I think the industry's focus on executing safe and high-quality science will continue."
Potential Impact on Research Collaborations
However, some experts express concern about potential ripple effects on research partnerships. Joshua Travis, associate director of ALZBrainTrust at the Alzheimer's Association, warns that organizations dependent on government funding might face challenges if they collaborate with pharmaceutical companies maintaining strong diversity initiatives.
"There are concerns that although pharma companies might not be punished, grant-receiving organisations may be," Travis explains. "If they work with pharma companies that continue to push diversity, they could receive retaliation with funding efforts through federal grants."
European Leadership in Diversity Initiatives
While the US grapples with these policy shifts, Europe is advancing its commitment to clinical trial diversity. A recently formed consortium of 73 regulators, companies, and trial sites has secured €66.8 million in funding for a six-year initiative to enhance trial diversity across Europe, demonstrating the global momentum behind these efforts.
Major pharmaceutical companies, including Eli Lilly, continue to maintain their DEI commitments, with dedicated resources and programs for both staffing and clinical trials remaining accessible on their corporate websites.
