What Is Real-World Data?

Real-world data is defined by its source. It’s any data that are captured at the point of care, in an actual clinical scenario or based on patient’s experience outside of the clinical setting. But this is not enough for it to be used in various phases of drug development to support evidence that guides decision-making and regulatory processes. Real-world data needs to be converted or translated to inform scientific inquiry, validate existing evidence and support decision-making on medical care interventions. The latter is especially important as it relates to understanding the impact of adverse events or rare side effects when a drug is used in a larger patient population once approved.