How can clinical trial sponsors help keep their research going amid the spreading coronavirus outbreak? Use virtual visits, phone interviews, self-administration and remote monitoring, the FDA says.
That's according to a new final guidance (PDF) document the agency published Wednesday describing the potentially unavoidable deviations from trial protocols that may have to be made to maintain the safety of study participants and providers. These methods could help studies weather challenges from quarantines and travel limitations as well as the possible closures of clinical sites or interrupted supply chains.
“The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” the FDA’s deputy commissioner for medical and scientific affairs, Anand Shah, said in an agency statement.
“We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants,” Shah added.
This includes decisions on whether to continue trial recruitment or the use of the investigational drug or device. In addition, the FDA said that any COVID-19 screening procedures performed do not need to be reported to the agency unless the data will be incorporated into the trial’s objectives.
Earlier this week, autoimmune disease outfit Provention Bio paused a phase 3 diabetes study “out of an abundance of caution” to protect its participants, providers and employees from the novel coronavirus. The company said it would provide an updated timeline at a later date.
In a note to investors, Jefferies analysts said that they haven’t yet seen an impact on companies’ early-stage trials. However, the industry “must prepare for a scenario where a 1-2 month potential pause is very likely,” and trials that require an in-person treatment administration or complex assessment like a biopsy—such as treatments for nonalcoholic steatohepatitis or breast cancer—could be paused for the foreseeable future.
“In a best case scenario—we see minimal impact or just a 1-3 month pushout of timelines,” the analysts wrote. “In a worst case scenario, we see trials that could be hugely interrupted due to missed biopsies and results or data that are uninterpretable or need to be repeated.”