Real World Evidence (RWE) refers to data and information gathered from a real-world setting, rather than being generated under controlled, clinical trial conditions. It encompasses diverse types of data, from a variety of sources. RWE may come from disease registries, insurers’ claims data, electronic medical records, or via pragmatic clinical trials, patient surveys, questionnaires, or observational studies.
RWE is a vital component of proving, and creating, value. Payers, providers, and patients are focused on outcomes, and RWE is the language in which those outcomes are demonstrated. RWE is not just about market access: it is also key to more efficient R&D, to personalized medicines, and to better-targeted marketing.
As the healthcare world shifts from volume-based payments to value-based payments, all stakeholders are focused on outcomes. RWE is the language in which those outcomes are demonstrated; as such, it is key to a more efficient, sustainable health system. RWE reflects how products are used and the effects they have in real-life clinical practice rather than in the highly controlled setting of a clinical trial.