The calls to increase inclusion of underrepresented groups in clinical trials have been around for a while. Diversity is not a new subject in the drug development world, but biopharmas have struggled to make good on including minority groups in representative numbers.
Now, Reify Health is attempting to give trial sites and drug sponsors insight into how diverse their studies are and ways to ramp up inclusion. The virtual clinical trials software provider released its Diversity Reporting feature last week.
“Improving diversity in clinical trials isn’t a 2021 issue. It’s a 2020s issue. We are taking a long-term view that starts with developing a quantitative understanding of where and why our industry is failing to engage certain communities," said Ralph Passarella, co-founder and CEO of Reify, in a statement.
Failure to have representative patient populations in clinical trials has been an issue for decades, and the numbers are stark.
Black clinical trial candidates are about 40% less likely to move into screening for a study than white candidates. For every 100 Black candidates, only 23 will enroll in the study, compared to 40 white candidates, Reify said, citing a sample of about 10,000 patients.
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Black, Hispanic and Asian Americans have historically been underrepresented in clinical trials despite comprising about 35% of the U.S. population, according to Yele Aluko, M.D., chief medical officer for EY Americas. That's more than 100 million Americans.
As recently as 2020, just 8% of patients in clinical trials supporting medicines approved by the FDA last year were Black or African American. Hispanic patients comprised 11%, and Asian patients made up 6% of the trials, according to the FDA's Drugs Trials Snapshot data.
"When you talk about decentralized clinical trials, we need to take a step back, first of all, and understand that the context of 130 million people being somewhat ignored, deprioritized, in clinical trials that take product to market is embarrassing. Therefore, clinical trials need to be innovated. One way to do that is to have decentralized clinical trials," Aluko said.
Reify's new tool will give drug sponsors live updates on how to improve patient diversity in their studies and insight on clinical trial enrollment strategies at individual and industrywide levels. Certain features entail informing sponsors whether sites are connecting with and prescreening candidates equally across demographics, whether certain groups have higher rates of attrition during the enrollment process and where more recruitment efforts are needed.