Janet Woodcock and Francis Collins dish on lessons learned from the pandemic
With almost 550,000 Covid-19 deaths in the US, it might seem hard to fathom any silver linings from such a tragedy. But NIH director Francis Collins and FDA acting commissioner Janet Woodcock did their best on Wednesday to explain what they’ve seen and learned and what the country needs to do to prepare for the next pandemic.
For Woodcock, who led the therapeutics side of Operation Warp Speed before returning to lead the FDA, Covid-19 clinical trial inefficiencies and a dearth of community-based research infrastructure sit atop her list.
While pointing to her publication last month in Nature Reviews Drug Discovery, she explained how just 5% of the almost 3,000 Covid-19 therapeutic trials were actually randomized and adequately powered to reveal actionable data.
“There was a tremendous amount of duplication, and a lot of small trials that yielded tantalizing information that sent people off to use treatments that were not useful and potentially harmful,” Woodcock said at the Milken Institute event. “In a global emergency we need to have more central coordination because we should really randomize the first patient.”
On the lack of research infrastructure, Woodcock explained how communities without academic medical centers or adequately trained personnel were stuck without any options for enrolling people in trials. “You can’t just build up infrastructure capacity in the middle of a pandemic,” she said. “We had tens of thousands of people dying from Covid and we couldn’t get enough patients enrolled in some trials.”
Collins, meanwhile, pointed to three lessons learned. The first is to ensure NIH and the pharma industry maintain its public-private partnership, known as ACTIV, which better coordinated and streamlined biomedical research resources for testing new and repurposed compounds to treat Covid-19.
“If we can do it in two weeks, as we did with ACTIV, we can probably do it again and make these kinds of partnerships,” Collins said.
Secondly, he pointed to the disconnect in the clinical trial networks in the US, noting Woodcock’s comments. While he said the duplicative and potentially unhelpful trials weren’t receiving funds from NIH, they may have been using NIH-funded infrastructure.
“We cannot let this clinical trial ecosystem fall back into this scattershot approach or we’ll be sorry. We need a much more rigorous approach. If we needed the evidence, we now have it,” Collins said.
And thirdly, he pointed to the need for continuing NIH’s venture capital-like strategy used in its RADx competition to speed new Covid-19 tests to market.
“There’s a lot of technologies out there,” he added, noting the Shark Tank approach may be better suited for many of the ones in development, as opposed to the NIH grant process, which can take more time.
Lastly, both Woodcock and Collins pointed to the need to increase the diversity of clinical trials, which Collins noted was a heavy lift for some of the Covid-19 vaccine developers.
“The way in which biomedical research works is contaminated by structural racism,” Collins said.
Woodcock echoed that sentiment, explaining how often trials are run in different countries but they don’t necessarily reflect the diversity of the US population.
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