Nav: Home

Editorial: A proposal to correct minority underrepresentation in clinical trials

January 01, 2019

LEXINGTON, Ky. (Jan. 3, 2019) -- In an editorial published in CNS Spectrums, Jay Avasarala, MD, PhD, takes the research community to task for its lack of minority representation 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, he urged researchers to make more effort to stave off the persistent slide in minority representation, which he believes 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 not a single study has compared how drugs 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 declined from 7.7% in 2002 to about 2% in 2013.

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

In the editorial, Avasarala proposed several changes to help spur minority recruitment, which will in turn improve the quality of data for minority populations and make it easier for physicians to treat their AA patients.

"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," 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 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.

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.

"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."

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

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.
-end-
CNS Spectrums, published by Cambridge University Press in association with the Neuroscience Education Institute, covers all aspects of the clinical neurosciences, neurotherapeutics, and neuropsychopharmacology, particularly those pertinent to the clinician and clinician investigator.

University of Kentucky

Related Multiple Sclerosis Articles:

New biomarkers of multiple sclerosis pathogenesis
Multiple sclerosis (MS) is a chronic debilitating inflammatory disease targeting the brain.
Using telemedicine to treat multiple sclerosis
Multiple sclerosis (MS) clinicians face continued challenges in optimizing neurological care, especially for people with advanced MS living in medically underserved communities.
Improving symptom tracking in multiple sclerosis
With a recent two-year, $833,000 grant from the US Department of Defense, kinesiology professor Richard van Emmerik and colleagues at the University of Massachusetts Amherst hope to eventually help an estimated 1 million people worldwide living with progressive multiple sclerosis by creating an improved diagnostic test for this form of the disease, which is characterized by a steady decrease in nervous system function.
An antibody-based drug for multiple sclerosis
Inserm Unit U919, directed by Professor Denis Vivien has developed an antibody with potential therapeutic effects against multiple sclerosis.
Four new risk genes associated with multiple sclerosis discovered
Scientists of the Technical University of Munich and the Max Planck Institute of Psychiatry have identified four new risk genes that are altered in German patients with multiple sclerosis.
PET detects neuroinflammation in multiple sclerosis
The triggers of autoimmune inflammation in multiple sclerosis (MS) have eluded scientists for many years, but molecular imaging is bringing researchers closer to identifying them, while providing a means of evaluating next-generation therapies for MS, say researchers introducing a study at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging.
Scientists find genetic cause of multiple sclerosis
Researchers have discovered a rare genetic mutation that makes it probable that a person will develop multiple sclerosis (MS).
ANKRD55: A new gene involved in Multiple Sclerosis is discovered
The Ikerbasque researcher Koen Vandenbroeck, who heads the Neurogenomiks laboratory which reports to the Achucarro centre and the UPV/EHU-University of the Basque Country, together with other national and international groups, has shown that a genetic variant in the 5q11 chromosome, which is associated with susceptibility to developing multiple sclerosis, greatly regulates a gene known as ANKRD55.
Children with and without multiple sclerosis have differences in gut bacteria
In a recent study, children with multiple sclerosis had differences in the abundance of specific gut bacteria than children without the disease.
Rituximab is superior to fingolimod for certain patients with multiple sclerosis
A new study indicates that rituximab is more effective than fingolimod for preventing relapses in patients with highly active multiple sclerosis switching from treatment with natalizumab.

Related Multiple Sclerosis Reading:

Overcoming Multiple Sclerosis: The Evidence-Based 7 Step Recovery Program
by George Jelinek MD (Author)

Multiple Sclerosis For Dummies
by Rosalind Kalb (Author), Barbara Giesser (Author), Kathleen Costello (Author)

The Wahls Protocol: A Radical New Way to Treat All Chronic Autoimmune Conditions Using Paleo Principles
by Terry Wahls M.D. (Author), Eve Adamson (Author)

Multiple Sclerosis, Fifth Edition: A Guide for the Newly Diagnosed
by T.Jock Murray MD (Author)

Awkward Bitch: My Life with MS
by Marlo Donato Parmelee (Author)

Multiple Sclerosis and (lots of) Vitamin D: My Eight-Year Treatment with The Coimbra Protocol for Autoimmune Diseases
by Ana Claudia Domene (Author)

Healing Multiple Sclerosis: Diet, Detox & Nutritional Makeover for Total Recovery, New Revised Edition
by Ann Boroch (Author)

Overcoming Multiple Sclerosis Cookbook: Delicious Recipes for Living Well with a Low Saturated Fat Diet
by Ingrid Adelsberger (Editor)

MS and Your Feelings: Handling the Ups and Downs of Multiple Sclerosis
by Allison Shadday LSCW (Author), Stanley Cohan M.D. Ph.D. (Foreword)

Live Your LIfe, Not Your Diagnosis: How to Manage Stress and Live Well with Multiple Sclerosis
by Andrea Hanson (Author)

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Approaching With Kindness
We often forget to say the words "thank you." But can those two words change how you — and those around you — look at the world? This hour, TED speakers on the power of gratitude and appreciation. Guests include author AJ Jacobs, author and former baseball player Mike Robbins, Dr. Laura Trice, Professor of Management Christine Porath, and former Danish politician Özlem Cekic.
Now Playing: Science for the People

#509 Anisogamy: The Beginning of Male and Female
This week we discuss how the sperm and egg came to be, and how a difference of reproductive interest has led to sexual conflict in bed bugs. We'll be speaking with Dr. Geoff Parker, an evolutionary biologist credited with developing a theory to explain the evolution of two sexes, about anisogamy, sexual reproduction through the fusion of two different gametes: the egg and the sperm. Then we'll speak with Dr. Roberto Pereira, research scientist in urban entomology at the University of Florida, about traumatic insemination in bed bugs.