Diversity, inclusion lacking in MS clinical trials, real-world studies
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SAN DIEGO — A systematic review of 25 years of MS-related clinical studies revealed a lack of diversity, inclusion and representation, which can affect patient treatment and outcomes, according to a presenter at ACTRIMS 2023.
“Diversity and inclusion are complementary, but they are not interchangeable terms,” Leorah Freeman, MD, PhD, a neurologist at the Mulva Clinic for the Neurosciences at University of Texas at Austin, told those in attendance. “Multiple sclerosis does not discriminate.”
Freeman sought to provide new evidence on the underrepresentation and underreporting of non-white individuals with MS both in clinical trials and real-world studies, to explore benefits of mindfully inclusive research and to identify barriers to equitable participation.
“We need generalizable knowledge to make clinical and regulatory decisions, and by enrolling diverse populations in clinical research, it can help us capture the wide range of experiences that can impact clinical outcomes,” she noted.
Freeman and colleagues conducted a systematic review of 45 phase 3 clinical trials involving FDA-approved, disease-modifying therapies for MS between 1995 and 2020. Results showed that more than one-third of reviewed materials neglected to report on race, one-third reported race and ethnicity solely through the percentage of white participants and less than a third reported on two or more races or ethnicities. Researchers also found that websites featuring DMTs failed to report on race or ethnicity of trial participants.
In addition, older adults with MS were often underrepresented in MS research compared with younger persons diagnosed with the disease, and, compared with multinational census data, non-white MS patients were significantly underrepresented in MS trials and in real-world studies.
Freeman also noted that mistrust, lack of awareness or information regarding clinical trials, language barriers, inherent or implicit bias, choice of trial location and lack of communication all contribute to the lack of representation in research.
“We need to promote belonging, trust and collaboration in MS research,” Freeman stated in her presentation. “We need to build trust by building long-lasting, authentic relationships with our patients, their families and our communities at large.”