Real-World Data And Real-World Evidence

Real-world data (RWD) encompasses information related to patient health status and the delivery of healthcare that falls outside traditional randomized controlled trials (RCTs). These data sources include electronic health records (EHRs), wearable technologies, connected devices, medical claims data, and various product, patient, and disease registries.

As the clinical research landscape evolves, RWD play a crucial role in complementing conventional RCTs by capturing insights that more accurately reflect everyday clinical practice. Decentralized and pragmatic clinical trials — randomized studies that incorporate real-world elements — bridge the gap between controlled research environments and actual patient experiences.

By integrating RWD into these innovative trial designs, researchers and clinicians can generate real-world evidence (RWE) that enhances understanding of treatment effectiveness, safety, and patient outcomes in routine care settings. This added dimension of evidence supports more informed decision-making, improves the relevance of study findings, and contributes to a more holistic view of medical impact. Ultimately, leveraging RWD and RWE allows stakeholders to design more efficient, patient-centered studies and accelerate the translation of research into real-world clinical benefits.