Definition

Clinical evidence about use and benefits/risks of a medicine derived from analysis of RWD (FDA). Used to support regulatory decisions including post-market safety.

Example

Claims database study to estimate incidence of a rare AE in a treated population.

Regulatory source

FDA RWE Framework, EMA RWE reflection paper, ICH E19

Common mistakes

Presenting RWE as definitive without discussing limitations and bias.

Inspector question

When have you used RWE for safety evaluation and how was it validated?

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