For COVID-Impacted Trials, Investigators Should Practice Remote Assessments Beforehand, US FDA Says

20 Apr 2020

Agency emphasizes feasibility and consistency when it comes to remote administration of clinician-reported and performance outcome assessments in studies disrupted by the pandemic; latest guidance update also discusses remote site monitoring, as well as alternative procurement and administration of investigational products.

Sea stones laid out in the form of a circle — Remote outcome assessments should be conducted in a consistent manner to minimize variability, US FDA says. • Source: Shutterstock

The US Food and Drug Administration is emphasizing feasibility and consistency when it comes to remote collection of performance and clinician-reported outcome assessments in clinical trials impacted by the COVID-19 pandemic.

In the latest update to its guidance on conducting clinical trials during the novel coronavirus public health emergency, the...