FDA guides on running clinical trials during coronavirus outbreak
The FDA has responded to concerns about the impact on clinical trials of the novel coronavirus with guidance on how to modify trial designs to mitigate the impact of the COVID-19 crisis.
Trials are already being disrupted by the coronavirus outbreak, with quarantine measures, site closures, travel limitations and interruptions to supply chains possibly interfering with research efforts.
US biotech Provention Bio has said it has paused a a trial of its type 1 diabetes drug teplizumab and Biogen is struggling to contain an outbreak of the disease among its own staff.
French biotech Sensorion has said that the outbreak will delay readout of a therapy for sudden hearing loss until midway through next year.
COVID-19 is likely to play havoc with research by making it difficult to administer drugs or therapies in line with trial protocols, preventing visits to clinics and lab or diagnostic testing, the FDA said.
In the guidance the FDA noted that safety of trial participants is paramount, and added that sponsors must consider whether participants’ safety is best served by continuing on a trial protocol or whether participation should stop altogether.
Phone or virtual assessments should be considered, along with virtual visits, and alternative assessment locations.
Alternative monitoring arrangements may be necessary and in some cases trial participants may need additional safety monitoring.
The FDA said that any COVID-19 screening procedures required by health systems do not need to be reported as protocols amendments.
Changes in visit times, missed times or patients leaving trials may lead to missing information – and the FDA said any missing data should be summarised in the clinical study report.
Analysts from Jefferies have already warned that regulatory decisions by the FDA could be delayed, in a report discussing the impact of coronavirus on European pharma companies.
The FDA has already postponed most non-essential meetings through April that cannot be performed virtually, and the European Medicines Agency has followed suit.
Jefferies’ team noted that phase 1 healthy volunteer trials are already becoming harder to recruit, with potential subjects staying away from hospitals and medical centres.
Some companies are no longer recruiting patients in Italy or China, an issue that could become more widespread if other countries enter lockdown, Jefferies said.