Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic

On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Extraordinary measures may need to be implemented and trials adjusted due to quarantine, limited access to hospitals, and healthcare professional focus on critical tasks. Here is a review of selected elements of the guidance, interpretations and recommendations.