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Paula Hardeman , Physician Assistant
Your Guide to MS Clinical Trials
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Sponsored by Sanofi
21 Nov 2024 | ~5:08 Engagement Time
Clinical trials are a type of clinical research that involves humans to help improve our knowledge of different diseases or conditions. They also help determine whether new drugs or treatments are effective and safe for the population. In addition, clinical trials can evaluate the effectiveness of lifestyle and behavioral changes in managing different conditions or diseases.
People may have different experiences with a disease or condition due to different environmental exposures, health behavior (poor sleep), or ethnic or racial differences, resulting in different results or experiences with treatments. Thus, clinical trials that represent a diverse range of participants are essential. Science is learning that several factors can influence the likelihood of developing a disease or condition or influence response to treatment, such as age, biological sex, education, work history, health behaviors (sleep, diet, exercise), environment, genetics, and co-existing medical problems.¹ Diversity in clinical trials will ensure that the new intervention will benefit people of different backgrounds.
Historically, clinical trials lack adequate representation of women, minorities, other ethnic groups, and older adults. The results of clinical trials were based on the white male study participants.¹ As a result, these shortcomings caused gaps in knowledge and understanding of different diseases and conditions, which can lead to health disparities and poor outcomes.
Health disparities are differences in health quality among different population subgroups.² These disparities can be categorized in overlapping themes related to population type, geography, and risk factors. Population could refer to race, ethnicity, age, gender, sexual orientation, or ability. Geography could refer to urban versus rural areas or high-income versus low- or middle-income countries as defined by the World Bank. Risk factors could refer to lack of access and environmental factors.² According to the U.S. Census Bureau, 44% of the U.S. population comprises racial and ethnic minority groups.³ However, 75% of participants who participated in clinical trials in 2020, which led to the approval of 53 new treatments, were non-Hispanic white.4
Unfortunately, clinical trials in multiple sclerosis patients are not immune to this. Historically, MS was thought to affect primarily women of European descent. However, recent data has suggested that in the United States, a higher incidence of MS was found in Black Americans compared to White Americans.5 But in the last 25 years, only 7.8% of participants in phase III MS clinical trials were non-white people.6 A recently published systematic review reviewed 44 phase III MS trial publications and found that 17 trials did not report race or ethnicity, 14 trials reported race and ethnicity as a proportion of white participants only, and 14 trials reported two or more races/ethnicities.7
Due to the underrepresentation of minorities and other ethnic groups in MS clinical trials, healthcare providers cannot appropriately counsel their patients on the natural progression and treatment options. As a result, non-white patients with MS have poorer outcomes. In the U.S., Black patients with MS have been found to have earlier disability and severe MRI disease burden at the time of diagnosis.7
Clinical trials examine the effectiveness and safety of new treatments or interventions for different diseases or conditions for the population. Because people can have different experiences with a disease or condition, clinical trials need to include participants of diverse backgrounds. Unfortunately, currently, clinic trials, including MS, have had an underrepresentation of racial and ethnic minority groups, which has caused health disparities and poor outcomes. Thankfully, organizations are working to help close this gap, like National African Americans with Multiple Sclerosis Registry whose goal is to advance equitable care and outcomes for African Americans with Multiple Sclerosis. You too could play a key role in improving health disparities and poor outcomes for minority groups.
Read through our articles Why Should I Participate in an MS Clinical Trial? and Your Guide to Clinical Trials to learn more and consider participating.
