Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor post market safety and adverse events and to make regulatory decisions. The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.

Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches.