Establishing participant diversity in clinical trials has been a persistent challenge for the drug development industry for a multitude of reasons, including language barriers, limited access to sites where studies are being conducted and even issues of trust in medical professionals. However, the fact that minorities show a greater incidence of certain diseases compared to Caucasians makes it imperative that investigators do more to include them in studies of new therapies.
Now, a neurologist from the University of Kentucky has proposed three changes to the research process which could help encourage the recruitment of minorities into clinical trials. Dr. Jay Avasarala uses multiple sclerosis (MS) – a disease which is often more aggressive in African Americans – as an example in his editorial published in the journal CNS Spectrums.
“The MS phenotype in the African American patient is an ideal model to study drug efficacy since the disease follows a rapidly disabling course,” wrote Avasarala. “African American MS patients admitted to US nursing homes are six years younger but more disabled compared to Caucasian American patients with MS. Since phenotypes between Caucasian Americans and African Americans can be clinically distinct, it is remarkable that not a single study has compared how drugs perform in such diverse groups.”
Avasarala reports that in 2002, 7.7 percent of participants in MS clinical trials were African American, however this number dropped to just two percent in 2013. Not only does this underrepresentation prevent the African American patient population from accessing potentially effective experimental therapies for MS, it also makes the safety and efficacy data collected from these trials largely inapplicable to these patients. As a result, it can be very difficult for prescribing physicians to predict whether a newly-approved MS drug will be effective in African American patients.
So, what does Avasarala propose the research community do to address this participant diversity issue? He suggests three changes to the way drug studies are conducted and their results reported on in order to increase transparency and encourage inclusion of minorities into trials in the future.
“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,” said Avasarala.
Since drug developers routinely continue to study the safety of drug products for years after they’ve been approved to meet FDA’s requirements, this first change shouldn’t be too difficult for pharma companies to comply with.
He also suggests that researchers should be required to provide reasons for why they were unable to include minorities in a trial before the results of their study be considered for publication. Currently, many papers fail to report adequate patient demographic data which can impede interpretation of results.
Finally, Avasarala believes that once a drug is approved, its drug package insert should include an efficacy statement that discloses whether conclusions on a drug’s effectiveness can be made in non-Caucasian patient populations. This requirement could help physicians make more informed decisions when deciding on a treatment plan for minority patients.
But for Avasarala, the bottom line is that more resources should be dedicated to including African Americans and other minorities in clinical trials from the start whenever possible. In addition to having an obvious benefit for the patients, trial sponsors could gather more representative clinical data and enjoy a potentially larger eligible patient population for their drug upon approval.
“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,” said Avasarala.
Interestingly, while the clinical progression and presentation of MS in African Americans compared to Caucasians has been known to be different since the 1970s, researchers studying new therapies have largely ignored these distinctions.
“I feel powerless to help them,” said Avasarala, referring to African American patients with MS. “There needs to be a change. And change ought to begin in the form of a policy shift.”