LETTER RE: Multiple sclerosis in US minority populations: Clinical practice insights
JagannadhaAvasarala, MD, PhD, Greenville Health System, Greenville, SCjavasarala@ghs.org
Submitted February 23, 2015
The article by Khan et al.1 rightly points out that there are various reasons for under-representation of minorities in clinical trials for MS. I had pointed out in my recent JAMA viewpoint article2 that the enrollment of African Americans (AA) 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 MS patients 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 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 the 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, PlegridyTM, had Indians (from the subcontinent) as the second-highest cohort of MS patients
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.
References
1. Khan O, Williams MJ, Amezcua L, Javed A, Larsen KE, Smrtka JM. Multiple sclerosis in US minority populations: Clinical practice insights. Neurol Clin Pract 2015;e-Publish Ahead of Print: CPJ.0000000000000112v1-101212000.
2. Avasarala J. Inadequacy of Clinical Trial Designs and Data to Control for the Confounding Impact of Race/Ethnicity in Response to Treatment in Multiple Sclerosis. JAMA 2014;71:943-944.
3. Cree BAC, Khan O, Bourdette D et al. Clinical characteristics of African Americans vs Caucasian Americans with multiple sclerosis. Neurology 2004; 63:2039-2045.
4. Naismith RT, Trinkhaus K, Cross AH. Phenotype and prognosis in African Americans with multiple sclerosis: a retrospective chart review. Multiple Sclerosis 2006;12:775-781.
The article by Khan et al.1 rightly points out that there are various reasons for under-representation of minorities in clinical trials for MS. I had pointed out in my recent JAMA viewpoint article2 that the enrollment of African Americans (AA) 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 MS patients 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 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 the 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, PlegridyTM, had Indians (from the subcontinent) as the second-highest cohort of MS patients 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.
References
1. Khan O, Williams MJ, Amezcua L, Javed A, Larsen KE, Smrtka JM. Multiple sclerosis in US minority populations: Clinical practice insights. Neurol Clin Pract 2015;e-Publish Ahead of Print: CPJ.0000000000000112v1-101212000.
2. Avasarala J. Inadequacy of Clinical Trial Designs and Data to Control for the Confounding Impact of Race/Ethnicity in Response to Treatment in Multiple Sclerosis. JAMA 2014;71:943-944.
3. Cree BAC, Khan O, Bourdette D et al. Clinical characteristics of African Americans vs Caucasian Americans with multiple sclerosis. Neurology 2004; 63:2039-2045.
4. Naismith RT, Trinkhaus K, Cross AH. Phenotype and prognosis in African Americans with multiple sclerosis: a retrospective chart review. Multiple Sclerosis 2006;12:775-781.