Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says
Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.
You may also be interested in...
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
Biopharma companies struggle with which trials, if any, to pause or delay. Lilly said it wants to ease the burden on health care facilities, while Galapagos said its choice is related to patient safety.
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.