European Guidance Released for Sponsors Managing Clinical Trials During Pandemic

Courtesy of Centers for Disease Control and Prevention. Credit: Hannah A Bullock; Azaibi Tamin

The European Commission, the European Medicines Agency, and the Heads of Medicines Agency have published a new guidance for study sponsors on how to manage the conduct of clinical trials during the coronavirus disease (COVID-19) pandemic. It provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations (e.g., if trial participants need to be in self-isolation or quarantine, access to public places [including hospitals] is limited due to the risk of spreading infections, and healthcare professionals are being reallocated).

Please note that the new guidance was published without prior public consultation due to the urgency of the situation, and sponsors should be aware that it may change and be further updated due to rapid evolving situation in the European Union (EU). Sponsors are reminded to consider the national legislations in place in separate EU Member States, and to consult them to complement the new guidance regarding specific matters which may take precedence over the EU recommendations.

Edited by Gary Cramer