NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Confirmatory evidence could include, for example, adequate and well-controlled clinical
investigations in a related disease area, certain types of real world evidence20

Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.

Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.


https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence