Diversity Thought Leader Calls for Stronger FDA Guidance Actions

Otis Johnson, Chief Diversity, Inclusion, and Sustainability Officer, Clario

Stressing that “regulators [play] a key role in solving” the lack of diversity in clinical trials, Otis Johnson, chief diversity, inclusion, and sustainability officer at Clario and a member of the Association of Clinical Research Professionals (ACRP) Diversity Advisory Council, called on the U.S. Food and Drug Administration (FDA) to put additional force behind its recent guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials.”

“I think the guidance is definitely a step in the right direction,” Johnson notes. “It touches a lot of the key areas where action is needed. For example, it encourages submission of a plan to increase patient diversity for each trial, but it doesn’t go far enough,” he said last month during an event sponsored by G3 Life Sciences.

Johnson laments the optional and tentative tone in the guidance. “Throughout [it], there are reminders that these are nonbinding recommendations,” he says. “In other words, they are optional, and it is okay if you choose not to follow them. There are no consequences and no incentives.”

Johnson is also troubled by a perhaps unintended message in the guidance. “As a matter of fact, there’s a statement in [it] that could discourage efforts to deliver better patient diversity in clinical trials,” he cautions. “The statement implies that more patients may need to be enrolled to investigate any differences in drug response uncovered. This may discourage sponsors from pursuing more diverse enrollment.”

Johnson called on industry to step up its efforts to promote diversity in clinical trials. “We still have a lack of patient diversity in clinical trials. I believe we have not approached the problem with the sense of urgency that it deserves.”

Author: Michael Causey