Lack of representation of systemically marginalized and underserved populations in research studies is a significant and persistent problem in medicine. This lack of representation in research contributes to and compounds the health disparities and inequities facing these populations.
Indeed, the 2022 National Academies of Sciences, Engineering, and Medicine’s consensus report entitled Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups states: “The United States has long made substantial investments in clinical research with the goal of improving the health and well-being of our nation. There is no doubt that these investments have contributed significantly to treating and preventing disease and extending human life. Nevertheless, clinical research faces a critical shortcoming. Currently, large swaths of the U.S. population, and those that often face the greatest health challenges, are less able to benefit from these discoveries because they are not adequately represented in clinical research studies.”
Demographics of study participants are often vastly different from the demographics of the larger population. And demographic factors including sex, race, ethnicity, and social determinants of health all influence health outcomes. Social determinants of health are social or economic conditions in which people are born, live, work, and age that influence health. In people with MS, these demographic and social determinant of health factors also affect disease outcomes. For example, Hispanic/Latinx American and Black and African American people with MS have higher MS Severity Scores on average than white Americans, after adjusting for age and gender.
We have a problem in the MS world with vast over-representation of white people in our clinical trials… That’s bad for science, and it’s bad for people.
— Dr. John Corboy
In a 2023 report titled Enhancing diversity of clinical trial populations in multiple sclerosis published in Sage Journals, the authors explain the consequences of failing to include diverse and representative populations in clinical trials: “First, the findings may lack generalizability to the entire population of interest. Second, the lack of variation reduces the ability to evaluate the heterogeneity of disease biology and treatment effects. Third, it creates unequal access to the benefits of research and the perpetuation of health inequities, mistrust, lack of uptake of interventions, and harm from the use of ineffective or unsafe therapies.”
Understanding how treatment approaches and medications impact people living with MS of all races and ethnicities is critical for improving health outcomes and informing clinical care. Improving diverse representation and inclusion in clinical research is a shared priority for the Rocky Mountain MS Center and our partners at the University of Colorado.
“We have a problem in the MS world with vast over-representation of white people in our clinical trials,” says Dr. John Corboy. “Some of the MS disease modifying therapy clinical trials, for example, that were done in Eastern Europe were literally something like 98.5% white people. That’s bad for science, and it’s bad for people.”
Corboy recalled the recent DISCO-MS study which examined the outcomes of taking older adults with stable MS off their disease modifying therapies (DMTs). In fact, one of the main reasons the DISCO-MS study was undertaken was a lack of diversity in age — most clinical trials have an upper age limit for participation of around 55 years of age, so very little was known about DMTs in an older population.
Once underway, DISCO-MS had about eight percent African American participants, very few Hispanic or Latino participants, and almost no Asian participants. “But if you look at a number of different MS clinical trials, we did way better than some others,” says Corboy. “Some studies include only two or three percent African American participants, and we know that African Americans account for just about the same amount of MS that you’d expect in the general population —13 percent.”
There are many important and critically necessary efforts underway in the MS research community to improve the diversity and inclusion in clinical trials in MS. Key strategies include community engagement and education, diversity plans for studies, adaptive designs to broaden eligibility criteria, reducing implicit bias among healthcare professionals through cultural competency training, partnering with clinical trial sites that have a track record for diverse enrollment, logistical and practical adjustments to reduce study participant burden, and investing in building capacity for conducting clinical trials in underrepresented regions.
