The coronavirus pandemic has revealed “problems” with the state of clinical trials, Dr Janet Woodcock, the director of the Centers for Drug Evaluation and Research at the United States Food and Drug Administration, said this week.
There are currently more than 700 trials for coronavirus therapeutics underway in the US, Woodcock said.
Most are not going to tell doctors very much that’s useful, said Woodcock, who is also leading Operation Warp Speed’s search for new therapeutics against Covid-19.
Woodcock made her comments to the New England Journal of Medicine in a discussion that was posted online.
One of the concerns about the large number of trials is that they are started by different investigators and are each too small to have answers. Plus, there’s a lack of coordination among them.
“You take convalescent plasma — we don’t have a single trial,” Woodcock said. “Even though that’s been available for quite a long time, we don’t have a single trial that is large enough to yield answers right now, a randomized trial, and we’re supporting continued conduct of those randomized trials.”
The uncoordinated nature of these trials “is a really big problem,” Woodcock said, adding that the trials are “underpowered,” and many will never enroll enough patients to really yield data.
“And since many of these patients are in the community, they don’t have an opportunity to participate in trials, and so if tens of thousands of people who are ill and most of them cannot be entered into trials where we can learn knowledge quickly, this is really a challenge,” she added.
“We need as a community to come together after this and do some lessons learned and figure out how to respond better,” she said.