Real-World Data (RWD) consists of health-related data collected outside the controlled environment of traditional Randomized Controlled Trials (RCTs). Sources of RWD are diverse and include electronic health records (EHRs), claims and billing data, patient-generated data (via wearable devices or mobile apps), and patient registries. This information captures how a drug or treatment performs in diverse, routine clinical settings.
Real-World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of RWD. Regulators like the FDA and EMA increasingly use RWE to support regulatory decision-making, such as granting new drug indications, designing more efficient Clinical Trials, and monitoring post-marketing drug safety (Pharmacovigilance). RWE offers a more complete picture of patient outcomes and drug effectiveness in broader, less controlled populations than traditional trials, making it a crucial component in the transition to Value-Based Healthcare (VBHC) and personalized treatment pathways.
