eal-world data (RWD) are health data gathered outside a controlled clinical trial environment from sources like electronic health records, health insurance claims and even wearables. Translating RWD into robust, reliable real-world evidence (RWE) has the potential to transform the practice of health care and improve health outcomes for people around the world.
Typically, new medicines and medical devices are tested for safety and effectiveness in laboratories and in clinical trials among a relatively small group of patients who meet certain study-defined criteria. The availability of new RWD sources combined with advanced analytical methods now makes it possible to understand how a product works in much larger populations, across many different types of patients, in a variety of clinical settings, and over many years. As a result, RWD can help inform care and treatment decisions that are both more targeted and applicable to broader groups of patients.