- The Food and Drug Administration on Wednesday issued new guidance on how to run clinical trials during the outbreak of the novel coronavirus.
- The guidelines are meant to help account for the "unavoidable" changes study sponsors will have to make to their trial protocols. The FDA proposed a number of recommendations to help ensure the safety of patients and investigators while keeping important clinical research going.
- At least four biotechs this week have halted clinical trials, and more are likely on the way, which could slow the progress of several experimental drugs.
It was only a matter of time before the spread of COVID-19, the disease caused by the new coronavirus, began to disrupt clinical trials. This week appears to have marked a tipping point.
Since Monday, Provention Bio, Addex Therapeutics, Arrowhead Pharmaceuticals and Iveric Bio have each publicly disclosed delays to clinical trials.
Analysts expect more to come. Umer Raffat from Evercore ISI wrote Wednesday that "there is plenty of evidence that a serious slowdown of clinical trials in the works," citing numbers from clinical research organizations and discussions with certain medical centers. The National Institutes of Health, meanwhile, just instituted new guidelines for NIH-funded human studies.
Now the FDA is weighing in before the problem escalates widely.
Broadly speaking, the FDA, in its guidance, aims to be flexible and account for the unique challenge clinical research will face during the pandemic. But it's calling on those running studies to document everything, and keep patients, the agency and any review boards in the loop before any changes are made.
In guidance issued Wednesday, the agency outlined the threat ahead. Site closures, quarantines, travel limitations, supply chain problems, COVID-19 infections to staff and more could all disrupt studies that are already ongoing or planned. Though each clinical trial is different, these problems will make it difficult to keep many studies on track.
"FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or ... control measures," the agency wrote. Among them: pausing recruitment or monitoring patients less frequently, or even virtually, rather than through hospital visits.
There are even more difficult decisions to consider, such as taking certain patients off of experimental medicines altogether if the risks outweigh the benefits. Patients who stop treatment might need extra monitoring, the FDA noted.
Trial sponsors should detail specifically how COVID-19 impacts their trials — from missed study visits or patients who drop out to contemplated protocol changes. That will keep the FDA up to date so it can understand reasons behind any "missing data" and more accurately review the drugs being tested, the agency said.
"Robust efforts by sponsors, investigators, and [review boards] to maintain the safety of trial participants and study data integrity are expected, and such efforts should be documented," the FDA wrote. COVID-19-related trial issues are likely unavoidable, so "efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be important."