Developing common guidance and best practices for the use of real-world evidence (RWE) is among the four areas that global regulators have pledged to focus on in their collaborative bid to further enable the integration of RWE into regulatory decision-making.
RWE V RWD
Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
Real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.
Source: US FDA
Ensuring transparency around the use of RWE and real-world data (RWD), and harmonizing the terminologies used for RWE and RWD...