MS Research In Black And Hispanic/Latinx Communities Reveals Patient Wants And Needs

By Mitzi Williams, MD, FAAN, Joi Life Wellness MS Center, and Ashish Pradhan, MD, executive director and disease area lead, neuroimmunology, Genentech

Despite making up nearly one-fifth of the multiple sclerosis (MS) population in the U.S.,¹ Black and Hispanic/Latinx people living with this disease have been historically underdiagnosed and undertreated. Some studies suggest that MS is even more common in these communities than previously thought — and that people among these groups may also experience earlier onset of disease, more severe symptoms, and greater disability compared to their white counterparts.^2,3,4,5

Black and Hispanic/Latinx communities often face barriers to healthcare that can lead to less access and worse outcomes. These barriers can lead to less participation in clinical trials, resulting in these populations being vastly underrepresented in clinical research.⁶ In fact, in a survey of drug trial enrollments across diseases conducted by the FDA, people who identify as Black or of African descent and Hispanic/Latinx were shown to make up less than 5% and 1%, respectively, of people enrolled in trials.⁷ This trend has also impacted MS research, limiting the collection of complete and accurate data on the disease biology of MS in these populations. Until now. 

In 2020, Genentech and a team of researchers initiated the first-ever clinical trial designed exclusively to broaden our current understanding of MS in Black and Hispanic/Latinx people. Presented during ECTRIMS this year, the results of the Phase 4 CHIMES trial, or CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis, provided not only invaluable insights that will potentially improve outcomes for people with MS in these historically underserved communities but even wider learnings that the industry can leverage to achieve more inclusive research.

But to uncover these learnings, the research team faced a series of complex questions: How can we break through historical, and incredibly justified, feelings of mistrust experienced by these communities? How can our acknowledgment and support of key social determinants of health encourage greater participation in clinical studies?

The answers we began to uncover are equally complex. We took a closer look at the development of CHIMES and how our learnings can support future clinical trials that better represent real-world disease populations. 

Meeting Patients Where They Are

There are many firsts with CHIMES, including the locations we selected for its trial sites, which spanned academic institutions, hospitals, outpatient clinics, community centers, and healthcare provider practices across the U.S., Kenya, and Puerto Rico. This geographic spread enabled us to learn from populations who traditionally lacked access to participate in research.

For example, supporting research with biomarkers is especially important for understanding disease within the Black and African American community, due to a lack of research with historical anchors. When we look at other populations, for instance in the Hispanic/Latinx community, we often have a place of origin to compare to, such as Mexico, Cuba, or Spain. With the African American population, we've never had similar comparisons. Conducting our research in the continent of Africa represented an important step forward for this research as well as our understanding of what MS looks like, including how it presents and how it progresses, in the region. By enabling the examination of genetic profiles and ancestry, CHIMES will enable us to forge new, unchartered territory.

Connecting With The Community To Understand Their Needs

To design a clinical trial for a specific population, researchers must first listen to its community — patients, caregivers, and the physicians who treat them, as well as the trial sites and investigators in the local areas where these patients live.

In developing the CHIMES trial, using database searches, we first identified physicians who treated and represented the Black and Hispanic/Latinx patient communities, looking at research that had been published in this area and engaging with the authors to bring them together in an advisory board setting. We had our first meeting in Manhattan, pre-COVID, and continued to regularly engage with our advisory board throughout the process through regular virtual meetings. We structured our discussions in such a fashion that while we were open about our intent to conduct a clinical trial, our top priority was to understand their experiences, their burdens, and their ideas as the very first step in our process.

By allowing our advisory board to freely share their thoughts and concerns throughout the entirety of the trial development and execution, we made sure that they felt genuine ownership of the process. The lessons we learned were critically important. As researchers, we often hold preconceived notions related to patients’ wants and needs, but in speaking to our advisory board, their desires became clear. They said, “Don't exclude anything because you think this population won't participate. Listen to them. Develop the best trial possible, and the people will come.” And we found this to be true.

Applying Community Input To Build A Tailored Protocol

Before writing a single word of our protocol, we first considered the learnings of our advisory board.

We heard concerns from our board related to various social determinants of health — including issues such as transportation, childcare, as well as financial burdens⁸ — and made it a point to provide appropriate resources, as needed, that enabled people to participate. These needs can be seen in recent research across the field that point to complex health inequities tied to not only social determinants of health but cultural differences, including language barriers and gaps in cultural competency in the healthcare workforce, as potential roadblocks for accessing care and treatment.^{9. 10}

Further, we heard from our advisory board how clinical trial criteria can often be unnecessarily limiting and explored changes we can make without impacting our evaluation of efficacy and safety but, rather, opening up who can enter the trial. With this, we sought to ensure that we didn't automatically exclude populations with a higher risk of comorbidities and changed our clinical trial methods to be more inclusive. For example, we reduced the lower limit on neutrophil count from 1.5 to 1.3 in our exclusion criteria, which resulted in a much higher proportion of Black patients being able to enroll in the trial.

Finally, to identify potential trial sites, we engaged local communities (identified by geographic locations) that have previously lacked the necessary resources to support a trial of this kind — despite having populations willing to take part in the process, if the right support was in place. For instance, they might be located further away from an MS Center of Excellence or a leading research institution, or people in the area may not be able to easily travel or take time away from work to participate in trials.

Building Trust To Break Through Recruitment Barriers

Raising awareness of the trial and recruiting participants during the COVID-19 pandemic also presented challenges, as many critical resources were shut down. Throughout this time, trust between investigators and the patient community was key to ensuring these efforts were successful. In recruiting, we looked to identify communities to participate, and we then identified academic thought leaders, well-regarded practitioners, neurologists, and patient representatives within those communities to find the right patients and build on the trust already established. 

Because of the close relationships our trial sites, investigators, monitors, and coordinators had built throughout our protocol development, they were able to stay in close contact with participants, making sure their visits happened on time and were not impacted by the pandemic. Participants placed their trust in our sites and their facilitators to be able to safely attend their appointments — which was key to ensuring the trial continued.

Despite the uncertainty these challenges presented, the trial fully enrolled ahead of schedule. Backed by a robust protocol and educational materials, such as trial protocols and information available in Spanish and Swahili and thoroughly vetted by our advisory board, we broke through. By getting people involved in the trial from the very start, they understood this trial was directed toward their communities and was championed by members of their communities. Their involvement made all the difference.

Continuing To Challenge The Status Quo In Clinical Research

While we cannot expect that inclusive research will be achieved or solved through one study, we can use our learnings from CHIMES to move forward with a vision for the future where every person across our healthcare system has the opportunity to participate in trials and ultimately access the care they need. We can now see that clinical data that includes more representative patient populations can help realize the promise of personalized healthcare and optimize treatment outcomes for all. But to make this vision a reality, these actions must become part of our process, not just across our organizations but as a wider industry, with new standards that stretch across private and public entities alike. We also need to build on this work and explore new ways to unlock culturally relevant resources, education programs, and support.

CHIMES met a critical need by focusing on these previously underserved populations, and we look forward to a day where our learnings on recruitment and access are built into future clinical trials, ensuring that representation and equality are universal standards in all trials as our industry moves forward. When we can come to a point where these practices become a reflex, we will, in turn, bolster confidence across all communities we seek to serve. And by engendering participation, we can create a cycle of trust, where representative clinical trials become the norm.

References:

1. Hittle M, et al. Population-Based Estimates for the Prevalence of Multiple Sclerosis in the United States by Race, Ethnicity, Age, Sex, and Geographic Region. JAMA Neurol. 2023;80(7):693-701.
2. National MS Society. "Who Gets MS? - MS in the Black Community." Retrieved November 2020.
3. Mult Scler J Exp Transl Clin. “MS in self-identified Hispanic/Latino individuals living in the US.” Sep. 25, 2017
4. UT Health. “Research shows race is a factor in disparities of symptom prevalence and response to treatment in multiple sclerosis treatment”
5. National MS Society. MS in the Hispanic / Latinx Community. https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS/Hispanic-Latino-Resources. Accessed 2023.
6. U.S. Food and Drug Administration. Clinical Trials Shed Light on Minority Health. U.S. Food and Drug Administration Website. https://wayback.archive-it.org/7993/20180908114418/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063.
   htm. Published 2018.
7. U.S. Food and Drug Administration. Clinical Trials Shed Light on Minority Health. U.S. Food and Drug Administration Website. https://wayback.archive-it.org/7993/20180908114418/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349063
   .htm. Published 2018.
8. National MS Society. Quantifying the Impact of the High Cost of DMTs. Supplemental Market Research Report Detailing Findings Among African American and Hispanic People Living with MS. Available here: https://nms2cdn.azureedge.net/cmssite/nationalmssociety/media/msnationalfiles/advocacy/aa-hispanic-nmss-research-report.pdf Accessed: May 2023.
9. Annette F. Okai. “Advancing Care and Outcomes for African American Patients With Multiple Sclerosis.” Neurology.
10. Lilyana Amezcua, MD, MS. “Health Disparities, Inequities, and Social Determinants of Health in Multiple Sclerosis and Related Disorders in the U.S.” JAMA Neurology.

About The Authors:

World-renowned multiple sclerosis expert Mitzi Joi Williams, MD, is a board-certified neurologist, fellowship-trained multiple sclerosis specialist, author, international speaker, and researcher who is passionate about educating and empowering people affected by MS. Her specialized training and expertise make her a highly sought-after expert and thought leader in the field of neurology and multiple sclerosis, often called upon to speak nationally and internationally on topics related to advancing MS care.

Executive Director and Disease Area Lead, Neuroimmunology, at Genentech, Ashish Pradhan, MD is passionate about delivering high-quality and impactful medical solutions to improve the lives of patients living with neuroimmunological disorders. Ashish played a key role in the CHIMES trial, from its initial development and discussions with advisory boards to sharing the results at key medical congresses worldwide.