Woodcock Outlines Important Research Takeaways From COVID-19 Pandemic
While research done at academic sites often brings greater confidence in results, they are often slow, underenrolled and “clunky,” says Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), currently also head of the therapeutics arm of Operation Warp Speed.
To address the enrollment problem, she suggested “[getting] out of the academic medical centers” and “[setting] up support for the community to participate” in trials. She noted that academic networks have seen slow site activation, slow enrollment and other problems, partially due to a lack of resources to complete those tasks rapidly.
“I believe if we built really good platforms, that the pharmaceutical industry would participate, and that would allow funding to flow in,” she said. “I think the problem right now is academic trials are felt to be slow and clunky. We need to merge these enterprises together, that’s my belief. [As a regulator], I would prefer to see these trials done by a third party run by academic investigators, because I think that gives us the greatest confidence … however, they can’t be small, slow trials. We have to get them done.”
A silver lining, she said, is that platform trials and master protocols – which Woodcock has long championed – have seen a greater acceptance during the pandemic and have been responsible for much of the actionable data seen so far. In the future, master protocols and platform trials should be set up and ready to go for when another pandemic hits. The government will need to take the lead on that effort as it provides a significant amount of research funding and does not have the same agenda as pharmaceutical companies, she said. Additionally, there needs to be some agreement between investigators, scientific researchers and the medical community on how studies will be done quickly, she added.
In an interview with the New England Journal of Medicine last week, Woodcock said that although there are more than 700 COVID-19 therapeutics trials ongoing in the U.S., only 5 percent of them, approximately, will produce actionable data because many of the trials are small or are poorly coordinated.
“I think there’s a really big problem, because the effort has been uncoordinated, [and] these trials are underpowered. Even amongst those 5 percent, many of them will never enroll enough patients,” she said. “That’s the other thing we’re seeing, is that people aren’t enrolled. Since many of these patients are in the community, they don’t have an opportunity to participate in trials, and so we have tens of thousands of people who are ill and most of them cannot be entered into trials where we can learn knowledge quickly.”
A case in point, she said, is convalescent plasma research, which still does not have a single randomized trial large enough to produce answers right now. Operation Warp Speed, in its efforts to set up trials, has seen competition from many of the smaller therapeutics studies, Woodcock said.
Operation Warp Speed participates in calls with regulators from 40 or 50 nations at a time, during which Woodcock has presented global trial data and brought up the issue of a lack of actionable trials. She believes that regulators around the world agree that unity will be essential for dealing with the next crisis in a better way.
“There will be an opportunity for at least the regulatory community worldwide … and hopefully the medical ecosystem worldwide to come together and say, ‘we can do better, we can have a more coordinated and cohesive response,’ so wherever the next virus originates and starts to proliferate, we can jump in as a global enterprise and figure out how to treat it as fast as possible,” she said.