Improving MS Care Through Innovative Trial Designs: Daniel Ontaneda, MD, PhD


Following the 2024 ACTRIMS Forum, the associate professor of neurology at the Cleveland Clinic Lerner College of Medicine provided insight on the need to build creative trials for multiple sclerosis treatments. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

"We have to embrace smart, adaptive clinical trial design. The historical ‘one arm with medication A and one arm with medication B’ probably isn’t going to work. What we have to do is design trials that incorporate multiple arms. This is called a multi-arm approach, where you have one comparator arm versus three or four different medications."

Clinicians who treat patients with multiple sclerosis (MS) have been fortunate that there are several disease-modifying options to choose from. A 2016 study showed that in the previous 2 decades, clinical trials in MS established a success rate of 27%, defined as passing phase 1, 2, 3, and FDA approval, almost tripling the overall industry rate of 10%. Despite the advances in therapeutics for MS, most of them are geared toward reducing relapsing forms of the disease, and only 1, ocrelizumab (Ocrevus; Genentech), has been approved for progressive disease.

The theme at this year’s Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, was “Breaking Barriers in MS,” with one of the focuses on clinical trial design considerations. Several presentations focused on ways to build better, more efficient trials, including how to incorporate patients from underrepresented communities. Some of the discussion surrounded how to build high quality clinical trials, enrolling appropriate populations, and stopping ones that aren’t adequate.

Following the meeting, program committee vice-chair Daniel Ontaneda, MD, PhD, talked about the importance of finding new ways to innovate clinical trials. He spoke about the complexities with tackling progressive MS and the need for studies that incorporate multiple different therapies and multistage approaches. Furthermore, he stressed that flexibility with trials will lead to better outcomes and a greater understanding for how medications may interact.

Click here for more coverage of ACTRIMS Forum 2024.

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