Abstract Details

Title Bridging the Gap: Engaging Non-traditional Research Sites to Increase Participation in Multiple Sclerosis Clinical Research

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:00 PM-6:00 PM)

Poster/Presentation
Number 18-009

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.

Authors/Disclosures
Andrew Wolf, MD PRESENTER	The institution of Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. The institution of Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. The institution of Dr. Wolf has received research support from Genentech. The institution of Dr. Wolf has received research support from Rocky Mountain MS Center. The institution of Dr. Wolf has received research support from Michael J. Fox Foundation. Dr. Wolf has received publishing royalties from a publication relating to health care.
Patrick J. Bosque, MD (Denver Health Medical Center)	Dr. Bosque has stock in Merck . The institution of Dr. Bosque has received research support from Sanofi.
Stefan Sillau	Stefan Sillau has nothing to disclose.
Tatiana M. Kielty, BS	Miss Kielty has nothing to disclose.
Isabel Adkisson, BA	Ms. Adkisson has nothing to disclose.
Carolyn Valdez, MS	Mrs. Valdez has nothing to disclose.
Eric Engebretson (University of Colorado Denver)	Mr. Engebretson has nothing to disclose.
Melissa A. Geyer, PhD	Dr. Geyer has received personal compensation for serving as an employee of Sanofi.
Alex Lublin (Sanofi Genzyme)	No disclosure on file
Jeffrey M. Chavin, MD, FAAN (Sanofi)	Dr. Chavin has received personal compensation for serving as an employee of Sanofi. Dr. Chavin has stock in Sanofi.
Kavita Nair, PhD, FAAN (University of Colorado)	Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PhRMA Foundation. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MJH Lifesciences. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Anylam . Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Applied Patient Experience. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Esai. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MHJ Life Sciences. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for ICER. The institution of Dr. Nair has received research support from Genentech. The institution of Dr. Nair has received research support from Novartis. The institution of Dr. Nair has received research support from Genentech. The institution of Dr. Nair has received research support from Phrma Foundation. The institution of Dr. Nair has received research support from Bristol Meyers Squibb. The institution of Dr. Nair has received research support from Novartis. The institution of Dr. Nair has received research support from NINDS. The institution of Dr. Nair has received research support from Sanofi Genzyme. The institution of Dr. Nair has received research support from Kyverna Therapeutcis. Dr. Nair has a non-compensated relationship as a Board Member with Center for Improving Value in Healthcare that is relevant to AAN interests or activities.

��ɫ��

��ɫ��