Diversity of MS clinical trials necessary to improve outcomes for underrepresented groups

Key takeaways:

• Less than 1% of current MS-based literature is focused on underrepresented groups.
• The CHIMES trial specifically addresses the gap in MS trial diversity by focusing on Black/Hispanic individuals.

WEST PALM BEACH, Fla. — Inclusion of underrepresented racial and ethnic groups, along with older patients, patients from rural areas and uninsured patients in multiple sclerosis-targeted clinical trials is likely to improve outcomes, according to a speaker.

“There are marginalized groups that we know are not represented adequately in clinical research,” Mitzi Joy Williams, MD, board-certified neurologist and founder of Joi Life Wellness , said during her presentation at ACTRIMS 2024. “We want to be able to generalize our results, so ensuring we have diverse populations in our trials will allow us to do that more adequately.”

In 2020, the FDA issued four sets of recommendations on the subject, including a broadening of eligibility criteria, suggestions to design clinical trials in a manner which promotes participant diversity, a call to improve practices for recruiting participants from diverse backgrounds into clinical trials and to apply recommendations for broad eligibility to ensure greater representation in studies that examine treatments for rare diseases and conditions.

These guidelines were intended to address a wide range of underserved communities not limited to underrepresented populations such as Black and Hispanic adults; included on the list were rural citizens, immigrants, the LGBTQ community, older adults, patients for whom English is a second language, patients who are underinsured and patients with limited education. Failure to extend opportunities, Williams noted, may lead these individuals to experience higher medical costs, rates of illness severity, disease progression, lack of access to treatment and insurance as well as higher mortality rates.

According to statistics cited by Williams, less than 1% of all existing literature (136 of 60,000 articles concerning MS) covers research and clinical trials that involve Black or Hispanic individuals in the U.S., while a systematic review of all trials revealed average enrollment of Black or African American patients was less than 3%.

In an attempt to remedy the disparity, Williams serves as co-lead for the CHIMES trial, the first such study focusing exclusively on Black and Hispanic individuals with MS living in the United States.

The open-label, prospective, single-arm, multicenter study aimed to assess disease activity and biomarker of neuronal damage in approximately 150 Black and Hispanic persons with relapsing multiple sclerosis receiving treatment with ocrelizumab, with 50 participants enrolled in a sub-study examining cerebrospinal fluid as a biomarker of disease.

“Improving representation is urgent, it requires investment and intention,” Williams said. “It also requires other things like transparency and accountability and that is the responsibility of everyone who’s involved in research.”

Reference:

Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab. https://classic.clinicaltrials.gov/ct2/show/NCT04377555. Published Feb. 20, 2024. Accessed March 21, 2024.