The coronvirus pandemic prompted the FDA to relax some clinical trial requirements, so last-minute decisions to safeguard research participants won’t trigger the agency’s enforcement arm.
The Food and Drug Administration issued guidance Wednesday to help drug and device companies manage their clinical trials during the Covid-19 outbreak, the disease caused by the novel coronavirus SARS-CoV-2. Ongoing clinical trials face disruptions such as site closures, quarantines, travel limitations, and supply chain issues that could lead to shortages of the investigational drug or device, the agency noted.
If scientists running these clinical trials need to change what they’re doing in order to save the lives of research participants, the FDA is giving them permission to do so without first seeking clearance from ethics boards known as institutional review boards (IRBs).
“It’s clear that the COVID-19 pandemic is having a significant impact on all research that is in-progress,” David Borasky, vice president of IRB compliance of WCG, a research ethics company and large commercial IRB, said in a March 18 email. “The FDA guidance is significant both because it makes clear that there is regulatory flexibility when adapting these studies to the realities of COVID-19 and because it provides sites and sponsors with guidance about how to handle issues such as the inability to collect protocol-required data.”
Human testing that’s regulated by FDA or receives federal money must adhere to strict rules to protect research participants from undue harm. Typically the review boards must approve studies before anyone can enroll in them. Any deviations from that approved study protocol also must undergo an ethics board review. Under the guidance document, the FDA said scientists don’t have to wait for ethics board approval to implement life-saving changes, but they must notify the panels after.
“The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” Anand Shah, FDA deputy commissioner for medical and scientific affairs, said in a statement.
Any study changes must have proper documentation, which the FDA made clear will be a critical part of staying out of trouble later. The industry sponsor, researchers, and the ethics board must take steps to minimize the impact on the integrity of the clinical trial.
The FDA’s guidance comes two days after the National Institutes of Health issued a similar notice for its grant recipients. The NIH indicated it would be willing to extend some budget deadlines and request reimbursement for unanticipated costs related to Covid-19.
“Institutions should take all steps necessary to ensure the safety of all human participants and research staff involved in NIH-funded clinical trials and human subjects studies,” the NIH statement said.