Making diversity in clinical research more than a talking point

Stock art that suggests diversity in clinical research

[Image courtesy of Pixabay]

Not long ago, diversity in clinical research seemed like an obscure topic. Ben Enejo, a partner at Arthur D. Little, recalls mentioning the theme in the past and getting blank stares.

But the pandemic and the murder of George Floyd helped highlight the importance of diversity on multiple fronts, including in clinical research. As a result, there are growing collaborations between academia and the industry dedicated to the theme. The FDA has also released guidance on race and ethnicity.

In the U.S., about 75% of clinical trial participants were white in 2020, according to the FDA.

“Now, if you go back 20 years, I would say between 80% and 90% of clinical trials were not diverse,” Enejo said. “You could say we’re going in the right direction now.”

But while discussions on diversity in clinical research have escalated, “there’s a concern that companies are just [focused on diversity] to tick boxes,” Enejo said. “That negatively affects trust.”

To tackle the problem, pharmaceutical companies need to build community. “We need to get diverse populations enrolled in trials, stay in trials and be an advocate of those trials to others,” Enejo said.

A recent Pew Research study found that Black Americans were more likely than other U.S. adults to conclude that medical research misconduct is at least a moderately big problem.

Ben Enejo

Trust, of course, can be difficult to build and restore. “The first question a patient with a diverse background might have is, ‘Can I trust these guys?’ ‘Can I trust that they’re not using me to just fill a quota?'” Enejo said.

And trust remains a priority throughout the entire clinical trial process.

Some companies working to improve the diversity numbers of their clinical trials ensure their clinical research teams are diverse. It is vital that “diverse participants in clinical trials see someone who looks like them,” Enejo said.

Of course, diversity in clinical research is more than just a numbers game.

Clinical trial sponsors should work to enter into a dialogue with diverse clinical trial participants. Enejo recommended keeping in mind questions such as, ‘Can you help us fix this?’ ‘Can we collaborate?’

The goal is to “understand how we can build a better world together,” he added. “For me, that is quite a powerful theme, and it helps to build trust.”

Of course, improving diversity in clinical research will be a process. The industry is now in an awareness-generation phase. “We’re laying down the foundations required to enable the shift,” Enejo said.

Sponsors are also taking early steps to improve recruitment from underrepresented communities.

Regulators in Europe, the UK and the U.S. have issued guidance on diversity and inclusion in clinical trials.

Because diversity in clinical trials remains limited, it is vital that the industry shifts to the next phase, which involves “start setting targets and putting the infrastructure in place,” Enejo concluded.