Real-world data and real-world evidence are playing an increasing role in health care decisions.

FDA uses RWD and RWE to monitor postmarked safety and adverse events and to make regulatory decisions.
The healthcare 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 innovatively new treatment approaches.