Clinical Trials: A Proposal to Correct Minority Under Representation


In an editorial published in  CNS Spectrums , Jay Avasarala, MD, Ph.D., takes the research community to task for its lack of presentation in Phase III clinical trials for drugs to treat Multiple Sclerosis (MS).

Noting that the disease course of MS in African American (AA)  patients is more aggressive, I have urged researchers to make more effort to stave off the persistent slide in the  least  representation, which has skews efficacy and disability data and prevents physicians' ability to extrapolate Whether drugs are effective in these populations.

"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 perform in such diverse groups. "

According to Avasarala, a neurologist specializing in Multiple Sclerosis and neuroimmunology at UK HealthCare's Kentucky Neuroscience Institute, minority recruitment for  clinical trials for MS drugs has been declined from 7.7% in 2002 to about 2% in 2013.

In 2014, the FDA's CDER launched the Drug Trials Snapshots initiative that endeavored to increase the risk of drug trials and improve public transparency by providing drug trial data online. While Avasarala acknowledges that the initiative was a good first step, it emphasizes that it does not require drug package inserts to include efficacy from  minority populations , making it difficult for prescribing physicians to determine whether the drug will help patients from minority ethnicities.

MS management

"First, I believe we should require pharmaceutical companies to collect post-marketing data in all groups that receive FDA-approved drugs for MS management and classify responsiveness based on ethnicity," he said, noting that the FDA has required manufacturers to provide post-marketing data on drug safety for many years.

Avasarala also advocates for a requirement that package include intelligence 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.

Since the 1970's, science has documented that MS among African Americans is clinically distinct in its progression and presentation, according to Avasarala, but research into treatments that address their particular phenotype has not kept pace.

Scientific Community

"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 do not have the data. "

Avasarala states that his research at UK HealthCare will focus on the translational aspects of MS, datamining, the application of retinal imaging techniques to advance disease diagnosis, and studying in vitro blood-brain barrier models to facilitate drug transportation.