The article defines the terms «real-world data» (RWD) and evidence» (RWE); classification of RWD, advantages, disadvantages their overcoming are outlined; provides a description purpose collecting RWD.

Real-world evidence includes all health-related information, such as electronic health records, insurance claims, pharmacy records and wearables that are obtained outside of clinical trials. These data can provide critical insights into the natural history disease evaluate safety effectiveness treatment regimens used in practice. have been applied to varying degrees by global regulatory agencie...