European Medical Agency: Clinical Trials Require Substantial Changes Due to War in Ukraine.

The invasion of Ukraine has greatly impacted clinical trials in Europe, as the country housed many clinical trial sites. Sponsors of clinical trials are seeking guidance from the European Medicines Agency (EMA) on how to handle disruptions caused by the war. The EMA has stated that they are looking for solutions, but currently there is no single fix that would be applicable for all trials.

According to Tyler Patchen of Endpoints News, “While focusing on estimands (i.e. hypothesized treatment effects), the new guidance notes that the emergence of new, unforeseen disruptive events may require the revision of the pre-specified estimand and/or the addition of estimands may be warranted. But any substantial changes in the design and conduct of a trial should be appropriately documented, and follow the local regulations.”

To read more, click here.

(Source: Endpoints News, April 18^th, 2022)