ACTRIMS: Diversity in Clinical Studies

Jason Freeman, MD, MBA: Welcome to ACTRIMS 2023. I'm your host, Dr Jason Freeman, Medical Director, Novartis Medical Affairs, providing you updates from ACTRIMS 2023. The information herein is provided for disease educational purposes only, and is not intended to be, nor does it imply medical or diagnostic advice.

Jason Freeman, MD, MBA: Joining us today is Dr D'Andra Parker, Medical Science Liaison with Novartis Pharmaceuticals. We're going to discuss diversity in clinical studies.

D’Andra Parker, PhD: Thank you for having me.

Jason Freeman, MD, MBA: Thanks for being here. So, at this year's ACTRIMS, there was a noted focus on diversity in MS [Multiple Sclerosis] and diversity, in particular, in clinical trials. Can you talk to us about some of the variations in the diagnosis of multiple sclerosis based on either race, ethnic, or socioeconomic profile of MS patients?

D'Andra Parker, PhD: Great question. At the start of the congress, we had a very thorough presentation by the International MS Differential Diagnosis Consortium. They really kind of focused on this topic. One of the key takeaways that I got from it was Dr Amezcua’s presentation, speaking on disease presentation within our historically underrepresented populations. We see transverse myelitis; we see optic neuritis as the key markers within the presentation of their MS. She had a presentation ꟷ a few of her notes commented on the timing of when they actually present with their MS diagnosis. She spoke to some of the progression that we observe within this demographic, some of the biological changes like the CSF [cerebrospinal fluid] biomarkers and the variations there, some of those considerations when it comes to making those diagnoses. Then even tying back to considering of, like, birthplace or place of travel most recently, to make those important when you're making those considerations for those diagnoses. With socioeconomic status, she did highlight the importance of being considerate of education, access to resources, the use of even certain resources. Those are being certain barriers that can limit the timely diagnosis of historically underrepresented populations.

Jason Freeman, MD, MBA: Got it. How about some of the efficacy and safety data that are available with respect to disease-modifying therapies in MS patients? How about pregnant patients or again, patients of different ethnic or socioeconomic status?

D'Andra Parker, PhD: There was a lot of good data that was kind of covering within that breadth of topic and so we saw information really assessing some of the MS DMTs [disease-modifying therapies] in this space. We were able to see that looking at women who are either prior to pregnancy, during pregnancy or post-pregnancy, some of their clinical outcomes, some of their safety outcomes, and even some data on the babies that come from these mothers. Then if you want to look at race, ethnicity, there's some really good data kind of once again, looking at these therapies in comparison to what we're seeing with non-blacks, non-Hispanics. What's really nice too is that some of the data even teased out some of the biomarker differences that are there, the subtle differences that are there that might be important to better understand how these therapies work in these unique demographics.

Jason Freeman, MD, MBA: When patients talk to me, they often have the question, is it going to work for me? Has it been tested in patients that look like me? Can you speak to that?

D'Andra Parker, PhD: That's being addressed now. There's a lot more effort to really make sure that these studies are actually meant to look at the patients that are impacted by MS. We are getting a lot more data to suggest that visible minorities, underrepresented demographics, are really impacted by MS and they're impacted in aꟷit almost seems more severe and so we need to better understand what is happening there.

Jason Freeman, MD, MBA: Thanks for that. So, can you summarize some of the key takeaways from the presentations at ACTRIMS this year on diversity and MS studies?

D'Andra Parker, PhD: For sure. So, I guess the major takeaway is when we're imagining their disease, there needs to be conversations around health literacy, getting patients comfortable, getting them to understand what they're going through and be able to identify their own symptoms. Another big takeaway is when it comes to like the education that's needed, there's a big gap there and so there's a lot of highlighting on the importance of making sure that neurologists are informed so that they can maybe make those appropriate diagnoses and not have it where maybe this contributes to this delay in the diagnosis of MS. What else did we see? We saw that baseline parameters are very different within these underrepresented populations. So, when you look at B-cell levels or CSF biomarkers, we're seeing that those levels are also varied so it really does highlight to us that there are such unique differences and that we really just need to pay attention to that and be more aware of that so that when we are making these diagnoses, it's more informed.

Jason Freeman, MD, MBA: Got it. One last thing I think is talking about clinical trials and diversity in clinical trials. Obviously, we both work for Novartis and clinical trials are a large part of what we do. Can you talk about what can actually be done to increase participation in clinical trials among diverse populations?

D'Andra Parker, PhD: For sure. This is near and dear to my heart. This is a sweet spot for me. There's a lot that can be done, and there's a lot that is being done. So, it's meeting patients where they are. How do I get to the patient, as opposed to the old way we thought of bringing the patients to us? So, there's like decentralized trials as a way to get to patients more. So, there's the idea of partnering with community organizations, letting people know that you want to understand the disease within their demographics so that we can help them better as opposed to the question of do these DMTs, do these therapies even have they been tested in me? We can have that conversation so that we can then help with that recruitment and then have those numbers within our studies. I've heard of recently some trials are even doing it where they are. If there's an ability to actually, collect samples on-site, they're doing that as opposed to doing it where you now have to come to a different area to give your samples. There's a lot of things that can be done, and I think it's being done, and this is what we're seeing with this uptick in more diverse representation within our trials and more focus on making sure that everybody is represented in trials.

Jason Freeman, MD, MBA: I think a key part of that is trust and continuing to build trust in the different communities that we serve.

D'Andra Parker, PhD: I agree.

Jason Freeman, MD, MBA: Thanks for your time today, D'Andra.

D'Andra Parker, PhD: Thank you.

Jason Freeman, MD, MBA: Thank you for watching ACTRIMS 2023 updates sponsored by Novartis. We look forward to seeing you at AAN 2023 for more exciting updates.

Transcript Edited for Clarity