Califf wants more diversity in clinical trials. We just have to overcome the healthcare system itself

FDA chief Robert Califf, M.D., called for more work on boosting diversity in clinical trials while admitting that the healthcare system was set up in a way that creates disparities in care.  

As the FDA prepares updated guidance on ways to boost clinical diversity for research trials, Califf urged administrators to prioritize the issue Dec. 7 at the Milken Institute’s 2022 Future of Health Summit. The updated strategy will include input from several upper FDA leaders, such as regulatory science and innovation director Tina Morrison, M.D., and recently recruited Chief Science Officer Namandjé Bumpus, Ph.D.

“First of all, I think it's important to point out that we have made a lot of progress,” Califf said, adding that current NIH-funded clinical trials are looking “pretty good.” However, Califf’s not naïve to the issues still at hand, acknowledging that there is still a lot of work to do.     

“We really need to focus on solidifying and improving the gains we've made with regard to the standard age, sex, race, ethnicity, gender—those demographic characteristics where we know we can do better,” he said.

The FDA leader went on to add that geography must be considered, noting that people in rural areas of the U.S. “are really suffering.”

“If you live in a rural place three hours from the nearest endocrinologist and you have hard-to-treat diabetes, that's a big problem,” Califf said, following up that telehealth can be used to narrow some of those gaps.    

“That means more trials done at home, more district distribution of the technology, as part of clinical trials,” he said. However, the leader said he recognizes that that’s asking clinical trial systems to “overcome a health system which is structurally configured to create these disparities in the first place.”

Many clinicians would love to use telehealth, Califf said, but the tech isn’t being encouraged by the administrators.

“Clinical research doesn't happen in a vacuum—it's happening in the context of the health system that we're in,” he concluded. “And there's going to need to be progress in the health system.”