FDA guidance aims to help sponsors salvage trials disrupted by COVID-19

As COVID-19 safety concerns and social distancing measures continue to disrupt clinical trials around the U.S., FDA has released guidance to help investigators adapt the design and analysis of affected studies.

By the end of April, BioCentury found that 110 ongoing studies and 44 new studies had been delayed, with 11 trials halted indefinitely and a handful that were completed early or with incomplete data. Dozens since have been affected (see “Clinical Trial Disruptions Pile Up”)...