Abstract:
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Real world evidence plays a pivotal role in ensuring medicine safety in routine healthcare provision. With enhanced availability of real world data (RWD), and the establishment of initiatives which have provided infrastructure for large data network using electronic healthcare data (EHD), new methods to leverage EHD for safety signal detection/refinement/evaluation have emerged. In this presentation, we will discuss the evolving use of EHD through three examples that allow us to: 1. Support the contextualization of potential safety issues identified in the clinical development through Standing Cohorts on the Pfizer internal RWD data mart; 2. Show the added value of NLP of unstructured data by earlier detection of Acute liver injury than from structured data alone 3. Conduct rapid analysis queries across the distributed network of Sentinel data partners through the national resource IMEDS (Innovation in Medical Evidence Development and Surveillance), which was established by the FDA for private and public partner access of the FDA Sentinel system.
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