Designing an MS Clinical Trial Focused on Minority Populations: Mitzi Joi Williams, MD

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“We were very intentional about the way that we developed the trial. The steering committee included researchers of diverse backgrounds, but in our planning of the protocol, we also included patients, we included advocacy organizations, and we included input from Accelerated Care Project [for Multiple Sclerosis], which is a patient driven research organization. We tried to be very inclusive in the way that we developed the design of the trial.”

In order to address and better understand the underrepresentation of minority populations in multiple sclerosis (MS) clinical trials, the CHIMES trial (NCT04377555) was developed, set to include approximately 150 self-identified Black or African American and Hispanic/Latino patients with relapsing MS who are receiving treatment with ocrelizumab (Ocrevus; Genentech). Mitzi Joi Williams, MD, board certified neurology and multiple sclerosis specialist, and founder and CEO, Joi Life Wellness Group Multiple Sclerosis Center, spoke with NeurologyLive following her presentation at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), October 25-28, where she gave a presentation on the initiation of the study.

Williams outlined the trial design, describing the development as “very intentional” and inclusive, with organizers consulting an independent patient panel to ensure materials were culturally appropriate, as well as understandable. Researchers from diverse backgrounds were included on the steering committee, and during protocol planning, patients and advocacy organizations were consulted, with input coming from the Accelerated Care Project for Multiple Sclerosis. Williams also noted the relaxation of inclusion criteria to allow for patients with comorbidities to participate, provided transportation, as well as stipends for participation and childcare. Thanks to efforts to emphasize and advertise the study, enrollment has been completed 2 months ahead of schedule, Williams said. 

For more coverage of CMSC 2021, click here.