Multiple sclerosis in US minority populations

The article by Khan et al.1 rightly points out that there are various reasons for underrepresentation of minorities in clinical trials for multiple sclerosis (MS). I had pointed out in my recent JAMA viewpoint article2 that the enrollment of African Americans (AAs) has dropped from about 9%–10% in 1993 to a lowly 2% in more recent phase 3 clinical trials. This brings about a typical conundrum for physicians treating AA patients with MS since the data sets that are valid for Caucasian patient cohorts may not be applicable to the AA cohort, given poor enrollment numbers. The only way this malady would be addressed correctly would be for the US Food and Drug Administration (FDA) to set clear-cut guidelines for enrollment numbers. Without a set percentage number (as determined by statisticians) of patients enrolled, no study should be allowed to be filed for drug approval before the FDA. Without guidelines, data are likely to be doled out with no justice done to certain patient cohorts who may need the efficacy results the most. It is a well-known fact that AAs do poorly across all treatment regimen protocols in MS as well as likely have a more virulent or aggressive type of MS at onset.3 They also are more disabled earlier compared to Caucasians, as a group.4

As for minority enrollment in phase 3 clinical trials, it is also worth noting that the recently approved drug for MS, Plegridy, had Indians (from the subcontinent) as the second-highest cohort of patients with MS included in the phase 3 study, and AAs were not even mentioned as a group! So much for minority enrollment.

Disclosures:

The author reports no disclosures.