More Effort Needed to Recruit Minorities to Phase 3 Clinical Trials, MS Expert Says

More Effort Needed to Recruit Minorities to Phase 3 Clinical Trials, MS Expert Says

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.

4 comments

  1. Thank you for printing this. The authors and his respondents are
    absolutely correct. People of color are non-existent in medical trials. Another group in the same category of exclusion are people older than 70. For some reason the consensus seems to be that older people are not worth the money to fix ordinary problems and certainly not worth anything that might be expensive or take some thought to fix.
    The VA has a real problem in this area…an orthopedic surgeon asked if I wasn’t ashamed and didn’t I think I was too old to being taking the place of a younger vet in the VA medical system? He took out his anger by jabbing a steroid filled syringe repeatedly in the base of my thumb where my RA was giving much pain.

    • SuanM says:

      I would like to reply to not doing MS research on people 70 and over. Common sense tells me that at age where they are more likely to have health problems. And everything that happens during the
      research is reported. And I don’t feel that is likely that they would be consistent in the study.

  2. Dee says:

    I’m an African-American woman who’s had MS since 1995 only to discover after visiting an MS specialist that my neurologist who is Korean had been for the last eight years telling me there’s nothing to treat my RRM and that I had progresed to secondary progressive and he had nothing for me. I asked for a referral to get a second opinion from the new MS specialist and my neurologist was upset and was trying to block me from going to have just a second opinion After meeting the MS specialist in N. Cal Kaiser Permanente The MS specialist told me for eight years I could’ve been taking something I could’ve been slowing down the progression now eight years later I’m barely able to walk, my cognitive function is futurther impaired all because ??? was it racially motivated I don’t know I know that koren Dr. made a decision not to even discuss with me any options despite the fact I go to meetings and I hear /read about all these other drugs and he just told me there was nothing for me. As African-American individual recalling the syphilis study that took place many years ago where African-Americans participated in a Study of syphilis and were never given the penicillin that would have cured them they just used us as guinea pigs they were never told. There is a Lack of confidence that if we were in a trial would you ever really tell us the truth or would we be untreated guinea pigs again ?
    Please note that I’ve read studies I’ve read articles I’ve gone to meetings I was researching right along to see what else could I do to make things better I’m not a biologist so I count on my doctors being a part of my team that I could trust to direct as I asked the questions and that did not happen
    I’m a scientist by profession so I understand the significance of having a diverse group of people in your trials, it’s just you’ve got to work on your marketing to get the message out that people can be trusted and right now I have no trust after having personally experiencing a doctor deciding not to give me the truth all this time and my illness has progressed
    it may have done it either way I don’t know but that certainly caused me to lose confidence in what any doctor says to me now.

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