Because multiple sclerosis (MS) presentation and progression course can be very different between people of African ancestry and Caucasians, the recruitment of minorities to Phase 3 clinical trials is of particular importance.
Researchers in the MS field and the general MS community should make a greater effort to improve the recruitment of minorities to clinical trials to better understand “how drugs perform in such diverse groups,” Jay Avasarala, MD, PhD, a neurologist specializing in MS and neuroimmunology at U.K. HealthCare’s Kentucky Neuroscience Institute, wrote in an editorial published in CNS Spectrums.
The editorial is titled “FDA-approved drugs for multiple sclerosis have no efficacy or disability data in non-Caucasian patients.”
The number of therapies under development and already approved for the treatment of MS has grown rapidly over the past two decades. Still, Avasarala reports that, in the 11 years between the development of Rebif (interferon beta-1a, by EMD Serono) in 2002 and Tecfidera (dimethyl fumarate, by Biogen) in 2013, the enrollment numbers for African-Americans with MS in clinical trials dropped from 7.7 to 2 percent.
More recently, data from the U.S. Food and Drug Administration databases on Zinbryta (daclizumab, by Biogen) and Ocrevus (ocrelizumab, by Roche) further revealed a lack of information on the effectiveness of these therapies in non-Caucasian MS populations.
“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,” Avasarala said in a press release. “I feel powerless to help them. There needs to be a change. And change ought to begin in the form of a policy shift.”
In 2014, the FDA launched an initiative called drug trials snapshots aiming to encourage the inclusion of women and people from different racial, ethnic, and other minority groups in clinical studies.
Despite this effort, there is still little information about the demographics of patients participating in clinical studies. This represents an obstacle for physicians to understand “if drugs work in such poorly represented populations,” Avasarala wrote.
“It is time to consider changing the package labeling by law, and no publication ought to be accepted unless a minimum percentage of the recruited patients are represented by the African-American cohort,” he wrote. “Reporting baseline patient demographic data characteristics in the published literature must be made mandatory.”
Avasarala suggests possible changes that could be implemented in the event minority recruitment is not achievable, including post-marketing surveillance and data reports on a therapy’s efficacy in all minority groups by pharmaceutical companies.
“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,” he said.
He also suggested that package labeling should include efficacy data from minority populations.