New Study Highlights Lack of Diversity in Participants of Clinical Trials of MS Medications
February 8, 2022
Opportunities exist to increase participation of underrepresented groups in MS research
A new review shows that published results from more than one-third of phase III trials of disease-modifying therapies now used for the treatment of MS did not report on the race/ethnicity of trial participants, and another one-third only reported results on white participants. Understanding how medications impact people living with MS of all races and ethnicities is crucial to clinical decision making and improving outcomes. Resources for increasing the representation of diverse communities in MS research exist, and can be found below.
- Recent research suggests that MS impacts people of diverse races and ethnicities differently, and these differences may impact people’s responses to available therapies. For this reason, having data on how people from diverse backgrounds fared in clinical trials would help with treatment decisions once those therapies are approved and available. In general, clinical trials in MS have been conducted in largely white populations.
- Researchers at the University of Texas at Austin and collaborators conducted a systematic review of the medical literature from 1995 to 2020 to identify phase III trials for disease-modifying therapies – these are the pivotal studies that led to approval by the U.S. Food and Drug Administration to treat MS. The authors explored how race and ethnicity were reported in these papers, and if available, compared the participant population to multinational census data. They also looked at company-sponsored websites of these therapies to assess how information on race and ethnicity representation in trials was reported.
- The team reviewed 44 publications. Of these, 17 (37.8%) did not report race or ethnicity; 14 (31.1%) reported white participants only; and 14 (31.1%) reported on two or more races/ethnicities. People from diverse races/ethnicities were significantly underrepresented in the trials compared to census data. In addition, none of the treatment websites reported data on race and ethnicity from these pivotal trials.
- “Absence of diversity in clinical trials is a serious problem,” comment Drs. Roy Hoshi Hamilton and Olga Ciccarelli in an accompanying editorial. “It denies novel treatments to historically marginalized populations and advances treatments that may be suboptimal for the population at large.”
- The study authors make several suggestions for researchers, treatment manufacturers and trial sponsors to improve trial diversity, including addressing patient barriers like health literacy and distrust of healthcare providers/researchers, reducing implicit bias among healthcare professionals, partnering with clinical trial sites that have a track record for diverse enrollment, and investing in building capacity for conducting clinical trials in underrepresented regions. They also suggest that these groups and publishers improve proper reporting of ethnic and racial representation in trials to providers and patients.
- The National MS Society’s Corporate Healthcare Roundtable has established principles to increase inclusivity and address health inequities in clinical trials and data collection. Read them here
“Enrollment of Non-White Participants and Reporting of Race and Ethnicity in Phase III Trials of Multiple Sclerosis DMTs: A Systematic Review”
by Helen-Margaret Onuorah, Odelin Charron, Ethan Meltzer, Amanda Montague, Alexis Crispino, Avery Largent, Ashlea Lucas, and Leorah Freeman, is published in Neurology
(Published Ahead of Print on January 19, 2022).