Definition

Analysis of healthcare claims data (e.g., insurance) to assess drug use, outcomes, and safety in real-world populations.

Example

Medicare or commercial claims used to estimate incidence of hospitalization for AE X with drug Y.

Regulatory source

FDA Sentinel, EMA RWE paper

Common mistakes

Ignoring coding limitations and confounding in claims data.

Inspector question

What limitations do you document when using claims data for safety?

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