4.6 Editorial Material

Real-World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance

Journal

CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 106, Issue 1, Pages 28-30

Publisher

WILEY
DOI: 10.1002/cpt.1415

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Real-world data are data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources and include data from electronic health records, medical claims and billing data, data from product and disease registries, and data collected outside of health care systems, for example through mobile technologies. 1 Along with advanced analytics, they are transforming how US Food and Drug Administration (FDA) and the pharmaceutical industry conduct postmarket safety surveillance, which informs benefit-risk decision making.

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