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Better inclusion of minorities in clinical trials is needed to ensure all affected populations are adequately represented.

The cause of multiple sclerosis (MS) remains elusive. While there is ongoing research to test medications and treatment interventions, minorities can often be missing from research that informs treatment guidelines and recommendations for people living with MS.

Hispanic- and Asian-Americans have been found to have a lower incidence of MS than White Americans. However, despite previously held beliefs regarding incidence in Black Americans, recent studies show that Black Americans may have a higher incidence of MS than White Americans.1 An article published in CNS Spectrums states, “patient enrollment in people of color among pivotal trials for multiple sclerosis (MS)…continues to be dismal.”2 This article revealed that “…minority data are not typically available in most pivotal trial data publications making it a challenge to extrapolate a drug’s efficacy or side-effect profile when treating such patients”. In three pivotal clinical MS drug trials, the percentage of Black patients was <2%. This is not proportionate to the amount of the Black population living with MS.

Lack of an evidence-based approach to treatment and sparse knowledge of side effects in Black American populations can have adverse effects on patient outcomes, ranging from ineffectiveness to harm. A drug trial cited in the CNS Spectrums article did not study the metabolism rates of the drug siponimod in Blacks and Hispanics or consider the genotypic variant more common in these populations. For this particular drug, it was suggested that a warning be issued, relaying that more data needs to be collected. Additionally, the warning could include that the medication should be used mainly in the population it was tested on, which was White Americans until further data is obtained.2

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Better inclusion of minorities in clinical trials is needed to ensure all affected populations are represented appropriately. Intentional, targeted recruitment of minority populations may be one possible way to increase representation.

References

 

Khan, O., Williams, M. J., Amezcua, L., Javed, A., Larsen, K. E., & Smrtka, J. M. (2015). Multiple sclerosis in US minority populations: Clinical practice insights. Neurol Clin Pract, 5(2), 132-142. doi:10.1212/cpj.0000000000000112

Avasarala, J., Zachariah, P., & Turner, B. (2022). Pivotal clinical trial enrollment of Blacks in multiple sclerosis or neuromyelitis spectrum disorder: when will we achieve parity? CNS Spectr, 27(5), 527-529. doi:10.1017/s1092852921000183