[Use of real-world evidence in regulatory drug approval]

Real-world evidence (RWE) is gaining traction in political and scientific debate. The RWE debate revitalises discussions about causal inference by challenging the randomised controlled trial as a gold standard for demonstrating drug efficacy and effectiveness. This article outlines methodological challenges and possibilities for using RWE in regulatory drug approval. We argue, that more precise terminology and methodological considerations about study designs and data quality is needed, if the RWE debate is to inform new standards for evidence-based decision-making.