Mitzi Joi Williams, MD, founder and medical director of Joi Life Wellness Multiple Sclerosis (MS) Center, explains the issue of underrepresentation in MS clinical trials and the potential for digital health technologies to help overcome this barrier.
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.
Specialty Pharmacists at the Forefront: Elevating Care for Rare Diseases
May 1st 2024In the US, a disease is considered rare when it affects fewer than 200,000 persons, or 1 in every 1500 individuals, with an estimated total of 25 to 30 million Americans overall living with a rare disease at any given time.
Read More
Tackling Health Inequality: The Power of Education and Experience
April 30th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our final episode of this limited series and our conversation with Janine Jelks-Seale, MSPPM, director of health equity at UPMC Health Plan.
Listen
Latest Advances and Updates of Treatment in the Real World at AUA
May 1st 2024The annual meeting of the American Urological Association (AUA) not only presents the newest therapies coming out but showcases the latest in how treatments are being used in the real world, said Stephen Freedland, MD, of Cedars Sinai.
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
BRCA-Like Classification May Be a Useful Biomarker for Olaparib Response in Ovarian Cancer
May 1st 2024Adding olaparib to maintenance therapy with bevacizumab was associated with significantly longer survival for patients with ovarian cancer whose tumors have a BRCA-like genomic profile, but not among those with non-BRCA-like tumors, a study found.
Read More