Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
Abstract Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of efficacy and safety of medical interventions. More recently, a new paradigm is emerging—specifically within the context of preauthorization regulatory decision‐making—for some novel uses of real‐world evidence (RWE) from a variety of real‐world data (RWD) sources to …