Bridging the Gap: Engaging Non-traditional Research Sites to Increase Participation in Multiple Sclerosis Clinical Research
Andrew Wolf1, Patrick Bosque2, stefan Sillau1, Tatiana Kielty2, isabel adkisson1, carolyn valdez2, Eric Engebretson3, melissa geyer4, Alex Lublin4, jeffrey Chavin4, Kavita Nair5
1Neurology, University of Colorado Anschutz Medical Campus, 2Denver Health Medical Center, 3University of Colorado Denver, 4Sanofi Genzyme, 5University of Colorado
Objective:
The study examined collaborative potential between the University of Colorado MS Center (CU) and Denver Health (DH) to identify opportunities and barriers for non-traditional clinical trial site engagement in multiple sclerosis (MS) research.
Background:
Medicaid beneficiaries remain underrepresented in MS clinical trials, despite greater racial diversity. We examine the alignment of real-world care with traditional clinical trial protocols across two MS institutions.
Design/Methods:
This retrospective population-based study analyzed electronic medical records of patients with MS treated between January 1, 2023, and December 31, 2024, at two institutions: DH—Colorado's largest Disproportionate Share Hospital serving a predominantly Medicaid-insured population, and CU. Patients from both sites who met inclusion criteria were matched by age (±1 year), gender, and MS disease duration (±1 year), yielding two study cohorts of 168 patients each. We assessed the alignment between real-world clinical care and traditional MS clinical trial protocols by examining a) MS disease history and clinical management, b) Diagnostic assessments performed, c) Disease-modifying therapies prescribed and associated laboratory monitoring, and d) Emergency room visits and hospitalizations.
Results:
For the 168 matched samples, mean age was 42.9 (SD 12.4) years and 71.4% were female. The DH cohort had significantly higher Medicaid enrollment (46.4% vs 10.1%) and greater racial/ethnic diversity, with 32.7% self-identifying as Hispanic and 21.4% as Black compared to 8.9% and 10.7% at CU, respectively. MS phenotypes were similar across both cohorts (approximately 82-83% relapsing forms, 10-11% secondary progressive, and 6% primary progressive). Notable differences emerged in comorbidity profiles, with higher rates of anxiety (44.0% vs 36.9%), depression (44.0% vs 27.4%), and hypertension (32.1% vs 23.2%) in the DH cohort. MRI utilization for disease monitoring was comparable between institutions, with 90.5% of DH vs 83.9% of CU patients undergoing standard surveillance imaging.
Conclusions:
Despite serving different patient populations with varying resources, both institutions maintain similar approaches for MS management.
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