Abstract
Real-world evidence (RWE) is the term used to describe data that is collected from real-world sources outside of randomized controlled trials (RCTs). These sources can include electronic health records, claims data, patient registries, and observational studies. The use of RWE has grown in popularity in recent years to fill gaps in our understanding of the effectiveness and safety of healthcare interventions.1 While RWE does not replace well-designed RCTs, it plays an increasingly important role in clinical decision-making and health care policy because it provides additional data that may not be captured in an RCT, such as off-label uses, real-world prescribing patterns, rare or idiosyncratic adverse events, and cost-effectiveness.