Real world data


Real world data in medicine is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings, such as patient surveys, clinical trials, and observational cohort studies. Real-world data refer to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial. They are derived from electronic health records, claims and billing activities, product and disease registries, etc.

Real world evidence (RWE)

When working with RWD, the goal is often to generate evidence. The term real world evidence is highly related to RWD. RWE is defined by FDA as "clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD".

Regional context

US context

In December 2018, the FDA published a framework for Real World Evidence program.

EU context

In 2018, the EMA published a discussion paper on the use of patient disease registries for regulatory purposes.

Citations