What is real-world evidence (RWE)?
Real-world evidence (RWE) is the clinical evidence generated through the analysis of real-world data (RWD), which includes health information collected from electronic health records, claims databases, patient registries, wearable devices, and other non-interventional sources. RWE provides insights into treatment effectiveness, safety, adherence, and healthcare resource utilization in routine clinical practice. It can complement data from randomized controlled trials (RCTs) by reflecting more diverse patient populations and real-world conditions.
Why is real-world evidence important in the pharmaceutical industry?
RWE plays a growing role in regulatory decision-making, health technology assessment, and market access. It helps demonstrate the value of a treatment in everyday practice, supports outcomes-based agreements with payers, and identifies subpopulations who may benefit most. RWE is also valuable for post-marketing surveillance, label expansion, and strategic planning. As healthcare stakeholders increasingly demand data that reflects real-life clinical impact, RWE has become a critical component of evidence-generation strategies.
