Social Barriers Limit Multiple Sclerosis Trial Enrollment in the US

In the United States, patients with newly diagnosed multiple sclerosis (MS) who experience social deprivation face barriers to successfully enrolling in a clinical trial, according to study results presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress 2025, held in Barcelona, Spain from September 24 to 26, 2025.

Researchers from the Cleveland Clinic analyzed data from the DELIVER-MS study (ClinicalTrials.gov Identifier: NCT03535298), conducted in the US and the UK between 2019 and 2024, to examine whether social deprivation influenced participation in a clinical trial comparing early highly effective and escalation disease modifying treatment (DMT). The study included 870 patients with relapsing remitting MS, who either chose to enter a randomized or observational component of the trial. Patients who chose to be randomized were assigned either the early highly effective or escalation DMT.

Outcomes included the impact of social deprivation on successful enrollment, trial component choice, and DMT choice. Social deprivation was defined as the worst decile of the Social Deprivation Index for US participants and the worst decile of the Indices of Multiple Deprivation for UK participants.

The study population comprised 71% women, with a mean age of 36.1 years. A total of 45% resided in the UK, and 8.4% were classified as having social deprivation.

A subset of patients (n=44) were unable to complete study enrollment, which required a baseline visit, magnetic resonance imaging, and DMT initiation within 90 days. Social deprivation was associated with inability to complete study enrollment among patients in the US (odds ratio [OR], 4.15; IQR, 1.60-10.79). This pattern was not seen among those in the UK.

Similarly, patients with social deprivation who lived in the US were more likely to choose observation over randomization (OR, 2.47; IQR, 1.16-5.26), whereas this trend was not observed in the UK (OR, 1.41; 95% CI, 0.72-2.74).

In the observation study arm, social deprivation did not affect DMT choice in the US or the UK (OR, 1.45; IQR, 0.66-3.21).

The study authors concluded, “Individuals newly diagnosed with MS in the US who experience [social deprivation] may face barriers that inhibit their ability to participate in randomized clinical trials, which was not observed in the UK. Differences in healthcare systems or increased social supports in the UK compared to the US may account for these findings.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.