Addressing continuing disparities between observed and expected representation for racial and ethnic minorities in clinical trials will require a comprehensive, multifaceted approach from regulatory bodies, sponsors, and contract research organizations (CROs) aimed at prioritizing inclusivity at every stage of the trial process—from design to recruitment and implementation—according to the student creator of an award-winning poster presented at ACRP 2025.
The poster on “Understanding the Role of CROs and Sponsors During the Feasibility Process to Increase Enrollment for Racial and Ethnic Minorities in Clinical Trials” was judged the best of the 10 posters accepted for presentation at the recent conference in New Orleans, La. It is the brainchild of Jalen Denson, BSPHc, LSSWB, who worked on the topic as an undergraduate student in public health with the Department of Biology at Juniata College in Huntingdon, Pa., under the guidance of research advisor Tia Warrick, DHSc, MPH, CCRA, ACRP-PM, CEO of Lesous Consulting LLC.
Now a graduate student with the Master of Arts program in Intelligence and Security Studies offered for civilians by The Citadel (the Military College of South Carolina) and a Unique Sites Specialist with Sterling IRB, Denson has also served on institutional review boards for the University of Pittsburgh and the Pennsylvania State University. His research underscores the need for continued efforts to bridge the gap between scientific progress and the diverse communities it aims to impact, ultimately contributing to a more just and equitable healthcare system.
“Clinical trials are fundamental to medical advancements, yet racial and ethnic minorities remain underrepresented, raising ethical and medical concerns,” Denson says. With an emphasis on historical contexts, ethical considerations, and patient recruitment barriers, he analyzed ClinicalTrials.gov race/ethnicity data from 37 completed, interventional, industry-sponsored Phase III trials in patients over 18 conducted in four disease-specific categories across a five-year span ending in early 2022. The trials focused on hypertension (9), stroke (4), asthma (11), and type 2 diabetes (13).
After identifying the prevalence of each of the four conditions by race/ethnicity, Denson calculated the expected sample sizes for each race/ethnic group for the selected trials across the four domains and compared these to observed sample sizes for each race/ethnic group in the trials. “This detailed examination allowed for the identification of whether a specific race/ethnicity is underrepresented in clinical trials addressing diseases that disproportionately impact that particular demographic,” he explains.
Historically, racial and ethnic minorities have been underrepresented across clinical research domains, particularly in studies addressing diseases that disproportionately affect these populations, Denson adds. “This persistent issue poses significant ethical and medical concerns, as clinical trials lacking diversity fail to capture the full spectrum of human responses to medical interventions, limit the generalizability of results, and perpetuate inequities in healthcare access and outcomes,” he says.
Building trust through enhanced community engagement is critical, with partnerships established between researchers and local leaders to address longstanding mistrust, Denson says. “Cultural competency training for researchers and coordinators can help them better navigate the social, cultural, and linguistic barriers that often deter participation from underrepresented groups,” he notes. “Additionally, implementing targeted recruitment strategies that focus on these populations can ensure their inclusion, while transparency in demographic reporting and accountability measures can drive progress. Integrating diversity metrics into trial feasibility assessments and providing incentives for studies that meet diversity benchmarks represent actionable steps forward.”
Strengthening the role of patient advocates in the trial design process can further align research goals with community needs, Denson adds. “By fostering an inclusive and representative research landscape, clinical trials can better serve all populations, ensuring that advancements in medicine lead to equitable health outcomes,” he says.
Stay tuned for the Call for Proposals for posters to be presented at ACRP 2026 in Orlando, Fla., which will open in the weeks ahead.
Reported by Gary Cramer
