Advancing Multiple Sclerosis Treatment Through Research-Integrated Clinical Care

Multiple sclerosis (MS) care continues to advance as clinical research refines understanding of disease activity, treatment response, and long-term disability. For clinicians, a central challenge may be translating the rapidly expanding trial landscape into practical strategies that improve outcomes in everyday practice. Integrating research in MS clinics may not only support therapeutic innovation but also helps clinicians better evaluate benefit–risk profiles, anticipate adverse events, and select therapies aligned with patient needs and goals.

At the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 27-29, Charlotte, North Carolina, Mark Freedman, MD, MSc, HBSc, CSPQ, FANA, FAAN, FRCPC, director of the multiple sclerosis research unit at Ottawa Hospital, presented in a session titled,“Driving Discovery in MS: The Power of Research Integrated Care.” His talk explored how embedding clinical research in routine MS care can position clinicians at the forefront of emerging therapies and outcome measures. The session, chaired by Dawn Carle, RN, BScN, also featured perspectives on research as the foundation of MS progress, the clinic experience in navigating trials, and strategies for building sustainable MS research programs.

In an interview with NeurologyLive^®, Freedman expanded on these themes, emphasizing that MS clinicians “want to be on the forefront and the edge of the research,” and that participation in trials offers patients access to therapies not otherwise available outside the research setting. He described how firsthand experience with investigational agents allows clinicians to learn early how to manage adverse events and refine treatment decisions by the time a drug reaches the market. Freedman also highlighted the limitations of traditional end points, such as relapse rate and the Expanded Disability Status Scale (EDSS) and discussed how can clinical trials serve as a testing ground for more sensitive measures.

NeurologyLive: How do you currently see findings from research translating into actionable therapeutic strategies for patients with MS in clinical practice?

Mark Freedman, MD, MSc, HBSc, CSPQ, FANA, FAAN, FRCPC: This session was the brainchild of Dawn Carle, RN, BScN, who's moderated the session. One of the suggestions she made to the Consortium was that, with all the things that are going on here, why is there not a session on trying to integrate clinical research into your clinical practice? Is there any benefit to doing that? Nobody's really approached that, and their answer was, “Yes. Well, I think you should do it.” The next thing you know, we've got this session, and she asked me to try to incorporate some ideas.

We've been doing clinical research right from the get‑go. I think years ago, when the first clinical trials first came out, there were a lot of reasons why we wanted to do this. First of all, if you're a clinician and you're serious about MS, you want to be on the forefront and the edge of the research. You want to be doing things that may be the future for patients, and I think that gives some credibility to the clinic, that your interest is there. Plus, we're always striving to do better.

So, with the patients we have and the drugs that we are using today, how are we supposed to improve upon them? They're not perfect. We want to be able to gain information from doing trials. This not only gives the patients an opportunity to take something that maybe is not available to them otherwise—except through a clinical trial—but also, as an investigator, you get firsthand experience of what it's like to be on a particular therapy. Has there been any problem? How do you manage the adverse events?

By the time these drugs hit market, it could be 5, 6, 7, 8 years later, depending on the phase that you're involved with. So, you've now become an expert in a possible treatment that's going to evolve over the future, whereas if you wait for it to come out, it could be years before you gain that type of expertise. I think there are a lot of positives in doing clinical research.

As clinical trials in MS continue to evolve, which emerging end points or study designs do you believe are most effectively bridging the gap between bench research and meaningful, real-world patient outcomes?

We don't necessarily have perfect metrics. We design a clinical trial based on a primary outcome, and that is really an agreement with the regulatory agencies, be it the FDA, EMA, or whatever country you're in. When you design a clinical trial, you need to get the regulatory people saying, “Yes, if you do it this way and you get this outcome, it will be meaningful.” That's very important. But that one outcome may not be the whole story. You have to pick one. They don't let you pick 10 and then get your best ones, because then it's too easy to hit.

What other metrics could be used to back up your primary? Let's, for instance, look at relapse rate, because it's been used very frequently. Is that the whole story? Of course not. So what do you do? You use some other kind of more objective measures, like imaging, and almost always, when you look at new lesion formation, it goes hand in hand with the effect on relapses. We've always seen it, so it's like a check that the relapse effect is meaningful.

But what is really meaningful to the patients, of course, is disease progression. We don't have great metrics. We're stuck with the EDSS scale. It is a composite measure, but the authorities recognize it because it's been used for 50 years and it's been validated in many different studies. But it's insensitive. There are patients who tell you that they're worse, but the EDSS doesn't change.

Is there now an opportunity to introduce into a clinical trial a metric that might be better? But you have to validate it. Clinical trials are actually a great testing ground for something new—maybe a digital biomarker, maybe a footpad that collects gait, maybe a new cognitive measure that's more sensitive than the ones that take half an hour to run. Clinical trials give you that testing ground where you're collecting all this other data prospectively, and now you can marry it to something. You can get a new hypothesis coming out of a clinical trial, going, “You know, that was more sensitive than the EDSS. That's what we should be focusing on.”

For instance, this notion of progression independent of relapse activity has emerged from these trials. Should that now be the focus of a primary outcome measure? A lot of people think so. But that came out of several clinical trials.

Looking ahead, how do you anticipate discoveries in disease mechanisms influencing treatment selection and personalization in MS?

There's so much more that you can talk about in a clinical trial. When we did the very first one, I was involved with interferons in the ’80s and I was working as a basic neuroimmunologist as well. I had a laboratory and all such, and one of the reasons we got involved in the clinical trial was that there was an opportunity: if it worked, whatever that drug was—in this case it was interferon—was there something that we could study in the patients, looking at their blood, looking at their lymphocytes, looking at whatever the immunological measure was in vogue at the time?

Could we glean from those experiments who might have responded and who might not have, with the idea that we could use that in the future as maybe selection for the best patient for the best drug? Try to marry the 2 together. Understand: if it worked, why did it work? What's it doing immunologically in these patients? Because it's focused on the immune system.

This is another testing ground where you can now uncover mechanisms that may not have been suggested from the development of the drug, but when you put things into people, things happen that maybe didn't happen in mice, and you can pick those things up. That will help you in the future, possibly to determine who's a responder, who's not a responder, possibly who's going to have an adverse effect to the drug. You don't want to make people worse; you don't want to produce adverse effects; you want to avoid that. Could you mitigate against that by doing these experiments?

That's the opportunity to look. It would be a travesty to do a $100 million study and not collect information about all these other things that you have the opportunity to look into at the same time, even though it may not be directly in the protocol. It allows you to do other things. For example, PET studies: very novel, very interesting, very new, very expensive, very hard to do in the entire cohort. But if you're a center that is an expert in PET studies, could we take a small segment of patients that maybe are being tested at your site and put them through an extra test, and then we can look at some of the data that emerged from that and see how that fared with the rest of it?

I'll give you a little history. The very first study that led to the approval of interferon beta‑1b as a treatment for MS, there was no MRI in the protocol. There was no MRI. This was the ’80s. This was a new technique that hadn't really been tested well. One of the centers in British Columbia, run by the late Donald Paty, MD. Paty had this vision of MRI being useful in MS, and he went to the company and said, “You know what, we've got a lot of patients coming into this study. Do you mind if I put them through this machine and just collect data prospectively on it?”

Need I tell you the end result of this story? When they brought the data from the clinical study to the FDA to get approval for interferon beta‑1b based on relapse rate reduction, they went, “Doesn't really throw me.” Then Paty stepped up and said, “Well, let me show you something,” and he showed sequential scans of patients who were on the drug, where the lesions just suddenly vanished. The panel went, “Wow, that's really doing something.” But that was an add‑on study. One site said, “I’ve got this machine; maybe it's telling us something about the disease we didn't know before,” and look what the end result was. The end result was the FDA approved the drug, and everyone was now very excited about MRI, and the rest is history.

How do you see these historical lessons continuing to guide MS research‑integrated care and ultimately improve outcomes for patients?

There are centers that have expertise in genetic analysis, there are centers who are cognitive specialists. We all do this for various reasons. Take advantage of those centers. They're putting the patients in. It's really nothing to add but to try to get a study like that going just for the sole purpose of looking at whatever your particular metric is. The source of funds to be able to do that is nonexistent, or it's very difficult to obtain it.

But here’s industry going in with an intention of trying to prove benefit of something. It's no sweat off their back if we, in this process of doing this, discover something else about the disease we didn't know. Maybe they'll use it to their advantage. Like I said, maybe it'll show something about an adverse event that, if we saw that as a result of the study being done at one location, they can go, “Okay, if we leave these patients out, or anybody who has that abnormality in their blood, we don't treat them right away, we'll skirt around any serious problems.” That's what they're trying for. It's all about benefit–risk. If you can enhance and enrich the population who are going to benefit and not have harm, why not?

Transcript edited for clarity.Click here for more coverage of CMSC 2026.

REFERENCES
1. Freedman M. From Bench to Bedside: How Clinical Research Shapes the Future of MS Treatment. Presented at: 2026 CMSC Annual Meeting; May 27-29; Charlotte, North Carolina.