EMA Publishes Revised Methodological Guidance for Trials Impacted by Pandemic
The European Medicines Agency’s (EMA) latest revision to its guidance on trials affected by COVID-19 cautions sponsors against using unblinded data when assessing the risk of incomplete trial results and recommends they use an independent data monitoring committee for analysis if data must be unblinded.
In the guidance released on June 29, the EMA advises sponsors to plan ahead, if possible, for difficulties in data collection by recording information on the dates and durations of lockdowns and travel restrictions that prevent patients from getting to sites.
“In order to assist efficiently with the identification of deviations related to the COVID-19 pandemic that are of major importance for interpretation of trial results, sponsors should ensure that their existing systems are able to record pandemic-related protocol deviations and capture related reasons,” EMA says.
Information about COVID-19 testing or infection status at the individual participant level also should be recorded in trial documentation, the guidance says. And sponsors should seek scientific advice from the EMA early on if significant protocol modifications are necessary because of disruptions caused by the pandemic.
To read the guidance, click here: https://bit.ly/3gFIc9d.