Individuals from underserved groups are often underrepresented in clinical trials. This results in knowledge gaps regarding the effectiveness and safety of new medicines to treat illnesses among African Americans and Latinos, including diseases that disproportionately affect these populations, such as multiple sclerosis (MS). But a new clinical trial will assess a promising therapy for MS exclusively among Black and Latino individuals, reports Medpagetoday.com.
MS is an autoimmune disease that targets the brain and spinal cord. It affects more women than men and can trigger symptoms such as visual disturbances, muscle weakness, difficulties with coordination and balance, thinking and memory problems, numbness and prickly sensations. The cause of MS is unknown.
The clinical trial will investigate the effectiveness and safety of ocrelizumab—a drug that has been shown to reduce the rates of disease activity and progression in patients with relapsing MS and with the primary progressive form of the illness.
Dubbed CHIMES (Characterization of Ocrelizumab in Minorities With Multiple Sclerosis), the study was recently presented at the Consortium of Multiple Sclerosis Centers in Orlando.
CHIMES differs from other MS trials in that researchers teamed with patient advocacy groups and MS patients to design it. In doing so, they ensured that written materials and the study’s website included bilingual content that would be easily understood by Spanish-speaking patients or their family members. Recruitment sites were also selected with an eye toward diversity.
Mitzi J. Williams, MD, the medical director of Joi Life Wellness Group in Smyrna, Georgia, and the study’s lead investigator, explained: “One of the other major issues with a clinical trial enrollment is that many of the centers where the research is being done are not centers that have very diverse populations. And so we made sure that we try to focus on centers where there were diverse groups of patients so that they could be enrolled in the study.”
The trial also adjusted inclusion criteria that allowed for more Black and Latino people to enroll. “What we did was we looked at some of the criteria because we recognized that low enrollment at clinical trials is not just because of patient lack of participation, but that there are also systemic barriers that can interfere with enrollment,” Williams said. “So what we did was try to look at some of those barriers and remove some of them, so that we could have good, adequate enrollment for this study.” To that end, because Black and Latino patients tend to have higher rates of comorbidities, some criteria involving kidney function and hemoglobin A1C were relaxed somewhat.
Williams stressed the need to study MS in Latino and Black individuals because the illness affects such patients more severely. “There is more MRI disability, and there is more walking disability up to six years earlier than their white counterparts,” Williams said. “But there’s not really a lot of data to help us to understand why we see these differences because there’s exceptionally low enrollment of both of these groups in clinical trials.”
With the CHIMES study, researchers hope to change how future clinical trials enroll participants.
To learn more about multiple sclerosis, read “Multiple Sclerosis Onset Possibly Linked to Earlier Infection.”