The coronavirus vaccine race proves researchers need to step off campus more to meet patients in doctors’ offices and health clinics to improve clinical trials, something the FDA’s drug chief said requires “very serious soul searching.”
“Right now the situation for clinical trials with this disease is like starvation in the midst of plenty,” Janet Woodcock said at a Friends of Cancer Research leadership reception.
The rush to find a vaccine has left the Food and Drug Administration swimming in useless data. One agency analysis found just 6% of all clinical trials are yielding results the agency deems actionable, said Woodcock, who stepped away from her role as director of the FDA’s Center for Drug Evaluation and Research in May to join the White House’s Operation Warp Speed.
“The whole ecosystem needs to be fixed if we’re going to do something about it,” Ellen V. Sigal, chairperson and founder of Friends, said Wednesday. “But in Covid, it showed us the limitations of what we’re doing.”
A better, more inclusive clinical trial system requires changes across the board from the incentives for scientists running these trials to clinical trial design to how drug companies manage their studies, Sigal said.
‘Sea of Useless Studies’
Few clinical trials are producing meaningful results because researchers didn’t set up their studies to be randomized to eliminate bias in the results or the sample size of the study was too small to know if the results are statistically meaningful, Woodcock said.
Woodcock “is undoubtedly correct,” Vinay K, Prasad, a hematologist-oncologist who studies clinical trials and better decision making, said Wednesday.
“It represents one more failure in the response against Covid that the massive powers of the US Federal government could not organize simple, informative [randomized controlled trials], and instead observed a sea of useless studies,” he wrote in an email.
Bringing clinical trials where people live is a critical step in improving the diversity of the clinical trial population, especially for minorities hit hardest by the pandemic, Helene Gayle, president of Chicago Community Trust and co-chairwoman of a National Academies committee on equitable vaccine distribution, told a House Energy and Commerce oversight panel Wednesday.
“There’s a lot more to be done to make these trials accessible to communities of color,” she said. While a lot of groundwork has been laid out in clinical trial accessibility, “We just have to make it a priority and be intentional about it.”
Leading in Cases, Failing in Research
The U.S. is leading the world in Covid-19 cases, but “it seems like the vast majority of people aren’t making it into the clinical trials where we really do have important questions to answer,” Mark McClellan, a former FDA commissioner and Duke University professor said at the Friends event Tuesday. That is happening despite the efforts at Operation Warp Speed and mirrors what’s happening in other areas of biomedical research, he said.
Woodcock has long argued for streamlining a clinical trials system she’s called broken. But the clinical trials’ failure to generate evidence efficiently is amplified by the pandemic, which caused more than 7.1 million infections and 206,000 deaths in the U.S.
One possible solution could lie in legislation. Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) proposed a new FDA authority to fund grants in innovative clinical trial design in a concept paper. Feedback to the paper will form the framework for their follow-up bill to 21st Century Cures (Pub. L. 114-255), the 2016 biomedical innovation law that aimed to spur new medicines and devices.
But making those therapies widely available goes beyond clinical trials. Friends CEO Jeff Allen said it’s also important to put manufacturing processes in place early on and manage risks associated with early manufacturing so there isn’t a delay once the FDA makes therapies and vaccines available. “Then of course distribution of the products, which will pose its own challenges when you’re talking about a global distribution plan here.”
“I think we need to do some very serious soul searching after this is over,” Woodcock said.