ACTRIMS 2023: MS clinical research lacks diversity, representation
More efforts must be made to include Black, other nonwhite patients in clinical trials
Nonwhite populations are underrepresented in research that tests therapies for multiple sclerosis (MS), meaning most available data on a treatment’s effectiveness and safety can’t be generalized to all patients.
“The absence of diversity in MS research is a problem that concerns us all,” said Léorah Freeman, MD, PhD, a neurologist at the University of Texas at Austin, during a talk at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, Feb. 23-25 in San Diego. Freeman’s talk was titled, “Diversity and Inclusion in Clinical Research in MS.”
MS was long considered a white woman’s disease, but it’s become clear the disease is just as prevalent in many nonwhite populations, if not more so. In fact, research suggests Black people in the U.S. may actually be more likely to develop MS than their white counterparts.
Research also suggests MS tends to develop earlier and progress more aggressively among nonwhite people, who are already more likely to face health disparities due to structural inequalities in healthcare systems.
“Multiple sclerosis does not discriminate … people with MS come from all walks of life,” Freeman said.
Phase 3 clinical trials — rigorously controlled experiments that typically include hundreds of human participants — are the gold standard for determining how well treatments for MS work. Ideally, clinical trials should include a population that accurately reflects the overall population of people with the disease. This is rarely the case when it comes to race and ethnicity.
Last year, Freeman and her colleagues reviewed data from 44 Phase 3 clinical trials conducted between 1995 and 2020. These trials tested a range of treatments that were ultimately approved by the U.S. Food and Drug Administration (FDA) to treat MS.
Representation, diversity in clinical trials
About a third (37.8%) of these trials didn’t report any data on the race or ethnicity of their participants. Another third (31.1%) reported the percentage of white participants, but not other racial/ethnic groups. Less than a third (31.1%) reported the patient proportion for at least two different racial/ethnic groups.
Among 28 studies where data was available, there were substantially more white participants than would be expected given the overall racial makeup and rates of MS in the general population. Nonwhite populations, especially Black and Hispanic patients, were underrepresented.
Freeman noted that none of the studies from the U.S. had more than 10% Black participants — a markedly low rate given that more than 13% of the U.S. population is Black. “None of the trials were diverse enough to be representative of the Black population in the U.S.,” she said.
A few trials had near-representative proportions of Asian participants. These studies usually took deliberate steps to include this population, such as having trial sites in Asia, Freeman said.
Freeman noted that, in addition to clinical trials, real-world evidence studies also tend to include a disproportionate number of white patients. This lack of representation means there’s less data on MS treatments in nonwhite populations and the data that is available doesn’t accurately reflect the MS community.
“Lack of diversity in MS research leads to limited data on the real-world impact of MS, the effectiveness of treatments, and the structural, social, or biological factors driving disparities in MS outcomes,” Freeman wrote. “It also excludes people from historically marginalized communities from an opportunity to receive investigational medicines that have the potential to dramatically alter the severity of their disease.”
Structural, systemic issues affecting racial/ethnic diversity
Freeman said there are structural and systemic issues that will need to be addressed in order to promote nonwhite inclusion — ranging from economic disparities and language barriers to historical neglect and cruelty within the medical community that’s resulted in lingering distrust in many communities.
“Mistrust, lack of awareness or information about research, language barriers, researcher bias, or choice of trial location all contribute to the lack of representation of these communities in research. These barriers need to be addressed effectively to promote diversity and inclusion,” Freeman wrote.
While most of her talk focused on racial and ethnic diversity, Freeman said clinical trials often don’t include older patients or those with substantial disability scores, highlighting another area where research doesn’t fully reflect the diversity of the MS population.
Freeman offered several potential strategies that could help promote inclusion of more diverse populations in trials, such as innovative trial designs and trials in different locations to make it easier for underrepresented groups to participate.
She also emphasized the need for researchers — clinicians, academics, pharmaceutical workers — to be aware of their own biases and be deliberate about addressing them.
“I think the first step is for us all to realize that inclusion, promoting belonging in MS research today, is a shared responsibility. … All of us have a role in this,” she said, noting that while research suggests nonwhite patients are not less likely to participate in studies when asked, clinicians remain less likely to ask nonwhite patients to participate, likely due to clinicians’ implicit biases.
For this reason, it’s crucial that clinicians communicate clearly with all patients about opportunities in research and make efforts to build trust with patients from all walks of life.
“We need to break down those cultural myths [and] develop cultural competency so that we can ask all of our patients to contribute to research and benefit from research,” Freeman said. “Another key step for us to take is to build trust, to build trust with communities, and to build trust with our patients. It is all about building partnership, and this takes time, and it takes respect, and it takes vulnerability. … we have to work with our local communities, with our patients, with their families, with their caregivers, to promote belonging.”
Note: The Multiple Sclerosis News Today team is providing in-depth coverage of the ACTRIMS Forum 2023 Feb. 23-25. Go here to see the latest stories from the conference. Follow along on Facebook, Twitter, and Instagram for live updates using the hashtag #actrims2023.