FDA can do more to ensure diversity in clinical trials, experts say — including some constructive badgering
The Covid-19 vaccine and therapeutic development races have opened many eyes to the reality that clinical trials in the US rarely include the appropriate numbers of ethnic and racial minorities. And even when they sometimes get close, as with Moderna’s vaccine, the trial had to be deliberately slowed to recruit additional Black and Hispanic participants.
Experts convened on Monday as part of a workshop at the National Academies of Sciences, Engineering, and Medicine, and discussed whether the FDA might take a more prominent role in advocating for more diversity, among other topics to inform the ongoing work of the National Academies Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research.
“The FDA has an unrecognized ability to badger sponsors along the way,” said former FDA commissioner Rob Califf, who now works as an advisor to Google’s Verily Life Sciences. The FDA review teams also can check in on the data around the representative populations and put additional pressure on the sponsor, he added.
The agency published final guidance on clinical trial diversity last November, noting the extent of challenges for certain groups who continue to be underrepresented in many trials. But the guidance does not add any new requirements on ensuring diverse populations are enrolled in studies.
And it’s not just FDA. Califf said he’s pushing for a wider global discussion on how regulators can address diversity, noting that the public aggregation of information has to be done in ways that people can universally understand. There also needs to be a better system for tracking postmarket data and understanding how certain drugs affect certain populations and subpopulations.
“The gap between when a drug is approved and understanding how it should be used and how it affects subpopulations is just a gaping hole,” Califf said. “It can’t just be US only.”
Marsha Henderson, the FDA’s former associate commissioner for women’s health, also explained the importance of advocacy in pushing for diversity, noting that one of the only reasons an increasing number of women are now enrolled in clinical trials is because there was a consistent voice.
“FDA is notorious for not following up on certain issues because their resources are tilted toward user fees,” Henderson said. “I think it’s time for more surveillance.”
The recent example of Moderna slowing its Covid-19 vaccine trial for several weeks last September and October to allow for more non-white participants did little to shift the overall trial, which ended up with more than 60% white participants.
Melanie Ivarsson, chief development officer at Moderna, acknowledged to the workshop, with respect to her company’s racial and ethnic demographics in the vaccine trial: “Was it good enough? No. Could we have done better? Yes.”
She said the decision to stop enrolling white people for those few weeks came as “a big shock for the sites” as they were also running another vaccine trial for Pfizer, and they were preparing for trials from AstraZeneca and J&J, and “wanted to move along,” she said. “It’s not just industry who will solve this problem.”
Companies also don’t necessarily have to slow their clinical development programs to reach more diverse populations.
Melissa Gonzales, inclusion principal at Roche’s Genentech, explained to the workshop how, “If you go to the right sites, it’s not really a slowdown. Go to where the patients are actually seeking care, which takes some time to look into the clinical trial infrastructure. Do the work upfront and engage the community populations … You can’t just show up in the communities when there’s a trial they need.”
The comments follow similar sentiments expressed by FDA acting commissioner Janet Woodcock and NIH director Francis Collins. “The way in which biomedical research works is contaminated by structural racism,” Collins said.
Califf added on Monday, “If you want to look at structural racism, go two counties away from any big academic medical center and ask about access to clinical care … trials in the US are way ahead of clinical practice.”