BioPharma Dive December 4, 2023
Researchers have massive amounts of real-world healthcare data at our fingertips and when approaching a real-world evidence (RWE) deep analytics task, electronic health records are typically the first stop in terms of data gathering. However, there are a number of other important data sources, including structured data like healthcare claims and unstructured data such as patient-reported outcomes that should be considered and included for a complete view of the patient experience. Deep analysis of this information is used to generate novel insights and data repositories leading to RWE.
Recent draft guidance documents from the FDA offer an opportunity to use these types of data to support regulatory submissions.1,2,3 The FDA guidance documents elevate the importance of real-world data (RWD)...
Today's Sponsors
Today's Sponsor