Browsing: European Medicines Agency

This article discusses the European Medicines Agency’s (EMA) perspective on using digital health technologies (DHTs) for endpoint measurement in clinical trials, based on Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued between 2013 and 2022.

This study examines the role of real-world evidence (RWE) in European health technology assessment (HTA), focusing on its acceptance, use, and best practices across different HTA bodies. It analyzes the variability in RWE acceptance among HTA agencies and provides insights into the factors influencing its use in decision-making.