EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies. The actions presented in the report aim to holistically address the barriers and challenges experienced during the COVID-19 pandemic and the outbreak of mpox disease in setting up adequately sized clinical trials across multiple Member States that enable rapid gathering of sufficient, high-quality evidence to support robust decision-making by health authorities across the EU. 

The workshop was organised by EMA’s Emergency Task Force (ETF) and the European Commission (EC) on 9 June 2023, with participation from national competent authorities (NCAs), ethics committees representatives and academic sponsors.

The workshop discussions emphasised the need for larger studies across several European countries, speedier recruitment and delivery…