COVID-19: EMA New Guidances on Clinical Trials

The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic.

The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants, limited access to public places (including hospitals) due to the risk of spreading infections and reallocation of healthcare professionals. It also advises on how to communicate these changes to the national competent authorities.

It provides specific advice on clinical trials for COVID-19 treatments, including the need for large, multi-national trial protocols.

This in line with the CHMP’s call urging the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments.