Drug companies are flooding the space with treatment ideas for the novel coronavirus. A top US regulator warned Thursday that conducting all of these proposed studies will be a challenge.
Dr. Janet Woodcock, the longtime director of the US Food and Drug Administration’s drug division, said the agency has received over 950 proposals for coronavirus treatments.
“That’s a rather overwhelming amount in such a short time,” said Woodcock, who has been at the FDA since 1986.
“Although we may not run out of patients, unfortunately, we may run out of research personnel and time availability” to run the hundreds of trials being proposed, she said.
The FDA official argued for adaptive trials that can randomly test multiple drugs simultaneously and share one control group. Several of these studies are now underway.
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Hundreds of potential coronavirus treatments are being pitched to US regulators, and one top health official warned Thursday that there might not even be enough researchers to run all the proposed trials
Dr. Janet Woodcock, a longtime leader at the US Food and Drug Administration, said the regulatory agency has received more than 950 inquiries and proposals for coronavirus drugs.
“That’s a rather overwhelming amount in such a short time,” said Woodcock, who has worked for the FDA since 1986 and directs the Center for Drug Evaluation and Research.
Researchers are now testing 72 potential treatments in human trials, with 211 more programs in “planning stages” of development, she said.
Read more: We just got more promising data on Gilead’s potential coronavirus drug. Here’s everything we know about remdesivir and 14 other leading coronavirus treatments.
“You can see this is a massive effort,” Woodcock said. “Although we may not run out of patients, unfortunately, we may run out of research personnel and time availability to do that in this way of having separate development programs.”
Speaking on a webinar focused on designing high-quality COVID-19 virus studies, Woodcock said the current trial system has to change to meet the demand. It’s a position she has long advocated for, previously calling the US clinical trial system “broken.”
“This crisis underlies and points out the need to have a better clinical trial infrastructure in place,” she said Thursday.
Woodcock is pushing for adaptive trials that test multiple drugs simultaneously. Participants are randomized to receive one of several potential treatments. This allows multiple drugs to share a comparison arm — reducing the chance that patients will receive a placebo.
“Part of this early phase really ought to be to eliminate the less-promising agents and to pick out the promising agents,” she said.
Some of these adaptive studies are now underway. One UK-based study called RECOVERY is randomly testing five potential treatments in COVID-19 patients, and has quickly spread to include 170 hospitals across the UK.
Over the past month, that trial has already enrolled more than 7,000 people, said Dr. Martin Landray, one of the trial’s investigators and a professor of medicine and epidemiology at the University of Oxford.
“This is demonstrating that it is possible to deliver really large-scale, randomized trials with a control group in the context of a pandemic,” Landray said Thursday, “and generate the evidence that patients, doctors, and the health service so desperately needs.”
The US National Institutes of Health (NIH) and the World Health Organization have both launched their own adaptive trials. The NIH’s trial has focused on an antiviral drug called remdesivir so far, with results expected next month.
Read more: There are more than 70 potential coronavirus vaccines in the works. Here are the top efforts to watch, including the 16 vaccines set to be tested in people this year.
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