Correcting minority underrepresentation in MS clinical trials

Dr Jay Avasarala, a neurologist specialising in Multiple Sclerosis and neuroimmunology at UK HealthCare’s Kentucky Neuroscience Institute, commented on the unrrepresentation of minorities in Phase III clinical trials investigating drugs to treat Multiple Sclerosis (MS).

“The MS phenotype in the African American patient is an ideal model to study drug efficacy since the disease follows a rapidly disabling course,” he wrote. “AA MS patients admitted to US nursing homes are six years younger but more disabled compared to Caucasian American (CA) patients with MS. Since phenotypes between CA and AA can be clinically distinct, it is remarkable that not a single study has compared how drugs perform in such diverse groups.”

Dr Avasarala commented on how the progression of the disease differs in African Americans, and the fact that it is more aggressive could be beneficial in research. He urged researchers to make more effort to prevent minority underrepresentation, which could alter the efficacy and disability data, preventing physicians from extrapolating whether the drugs would actually be beneficial in African Americans.

According to the report, minority recruitment for clinical trials for MS drugs has declined from 7.7 percent in 2002 to about 2 percent in 2013. The FDA’s Center for Drug Evaluation and Research (CDER) launched the Drug Trials Snapshots initiative in 2014, with the aim to increase the representation of minorities in clinical trials, and to provide data online, thus improving public transparency. 

Despite this, Dr Avasarala noted that the move does not require companies to include efficacy data from minority populations along with the drugs which could make it difficult for doctors and physicians to determine whether a drug can actually help patients from non-white ethnicities.

He provided various changes that could be adopted to help resolve this issue; “First, I believe we should require pharmaceutical companies to collect post-marketing data in all minority groups who receive FDA-approved drugs for management of MS and classify responsiveness based on ethnicity.”

The FDA already requires manufacturers to provide post-marketing data, however Dr Avasarala argues that these should be more detailed to enable physicians to make informed decisions regarding their patients.

He also argued for a requirement that package labelling include efficacy data from minority populations and that no publication should accept study data without a clarifying statement that acknowledges the lack of sufficient data to make reasonable conclusions in non-Caucasian minorities.

“The scientific community has published reams of data , but all that matters to a patient is, ‘OK, doc, how can you treat me?’ “What drugs would you recommend?” And we fall short for African Americans, because we simply don’t have the data,” Dr Avasarala said.

“I feel powerless to help them. There needs to be a change. And change ought to begin in the form of a policy shift.”

The article was published in the journal CNS Spectrums.