Real World Evidence (RWE)

Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of 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). [From https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence]