Opportunities and challenges in supporting regulatory decision making with real-world evidence: findings from the EMA experience

A new report released by the EMA looks at the experience the agency has gained in conducting real-world data (RWD) and real-world evidence (RWE) studies during the period September 2021 to February 2023.  “RWE from studies led by regulators can complement evidence from other sources including clinical trials. … However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner.” The European Medicines Agency (EMA) has published a new report ‘Real-world evidence framework to support EU regulatory decision-making’ that summarizes their...