Diversity in clinical trials is crucial to their effectiveness, as they must accurately reflect the markets they will be deployed in to ensure that full safety and efficacy are tested. This is especially so for something as crucial as Covid, where clear demographic divides have been identified in terms of vulnerability.
Alas, new research from the University of Georgia suggests that the minority groups that are disproportionately affected by Covid are also disproportionately represented in clinical trials for treatments.
The researchers focus on the Adaptive COVID-19 Treatment Trial that is aiming to test the efficacy of remdesivir, and found that Black Americans make up just 20% of the total patient population. Similarly, in the trial funded by Gilead, just 10% of patients were Black. What’s more, Latinx and Native Americans only made up 23% of the former trial, and less than 1% of the latter.
“The overwhelming majority of the patients in both of those large clinical trials were Caucasians,” the researchers say. “Knowing that African Americans die at a higher rate than Caucasians, can I say that this medication will work in them as well? Yes, they enrolled a bunch of patients and yes they got these data out as fast as possible, but can we use this information to inform treatments in all patients?”
Diverse populations
The remdesivir trials showed that those given the drug recovered from the virus slightly quicker than those who only received placebos, but it’s widely believed that Black and other minority groups suffer from more severe symptoms and complications, so it’s not at all clear whether the drug was as effective for them.
“Why aren’t we putting up infrastructure for clinical trial sites in areas that were heavily hit by COVID?” the researchers ask. “If we would’ve included Albany, those clinical trials would’ve been more diversified and would’ve been much more representative of what the coronavirus pandemic looks like in our area and throughout the U.S.”
The researchers have done work previously on the importance of diversity in clinical trials, and they urge health care providers to use caution before deploying treatments on people that may not have been accurately represented during the trial process.
“I think the hardest question to address is what’s the harm? I have no idea what the potential long-term complications of these treatments may be. We don’t know. That’s what makes me the most nervous going forward,” they say. “We’re so prone and we’re taught that you always have to ‘do something,’ but sometimes doing something is the worst thing to do in that scenario.”
