Dr Mitzi Joi Williams: Digital Tools Will Help Make MS Clinical Trials More Inclusive

Mitzi Joi Williams, MD, founder and medical director of Joi Life Wellness Multiple Sclerosis (MS) Center, explains the issue of underrepresentation in clinical trials and the potential for digital health technologies to help overcome this barrier.

Williams discussed the topic at length at the Americas Committee for Treatment and Research in MS (ACTRIMS) Forum 2024 on March 2 during the session titled "Barriers in Clinical Trials."

Transcript

Could you please explain the issue of underrepresentation in MS clinical trials?

The issue of underrepresentation in MS clinical trials has been a long-standing one. When we think about our clinical trials, we obviously want very uniform populations, people with very little illness, very little variability so you can really see the effect of whatever therapy or intervention that you're trying to do.

However, we found that these trials traditionally have excluded certain groups of people. They're mostly conducted in Eastern Europe, so we're missing populations with ethnic diversity; we don't have very many people of African descent, people of Hispanic and Latino descent, or other ethnicities. We also are often missing our pediatric population, so the extremes of age—pediatric populations, which we know are affected by MS, as well as those over the age of 55. We're missing valuable data and how to treat these patients at the extremes of age.

Then, of course, there are also issues with those who are in underserved and rural communities, who may not be able to reach large academic centers that are conducting trials. We need more representation across a wide variety of groups and our clinical trials to make them representative of the people that we're actually serving with these therapies, interventions, and medications.

How does incorporating digital health technologies and remote monitoring impact clinical trial designs? How can these tools contribute to overcoming barriers in participant selection and outcome optimization?

I think that digital outcomes can really make a big difference in the way that we conduct clinical research. I think, in some ways, it can give us more accurate data than some of our examinations. Although our examinations are pretty good, I think we can get more accurate data about how people are doing over a range of time. Obviously, when we see them in the clinic, that is a time point, and they may be doing well at that time point, but it doesn't explain how they're doing later on in the day, or how they're doing over the course of a day.

I think it can give us additional data. I think also we should try to decrease the burden on our patients because it really is a privilege to us that they are participating and giving of their time and, in many cases, their bodies to help us find out how different interventions work and to help us to move forward the science. I think that digital tools will definitely be the way to go to help us to advance, making our trials more inclusive, but also improving the type of data that we're receiving.