Lexology December 1, 2023
The American agency Food and Drug Administration (FDA) innovated once again by creating a new guide on real-world evidence (RWE) and real-world data (RWD) to support drug approval.
The guide begins by defining exactly what real-world evidence and real-world data are, as outlined below:
Real World Evidence (RWE) – is clinical evidence based on the usage and potential benefits or risks of a medical product derived from RWD analysis.
Real World Data (RWD) – are data relating to the patient’s health status and/or the delivery of healthcare, which is routinely collected from a variety of sources.
The guide continues by presenting two important definitions that aim to establish distinctions between the interventional study and the non-interventional study, as explained below:
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