Publications by authors named "Haritha S Pillai"
The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).
Pharmacoepidemiol Drug Saf
October 2024
Article Synopsis
- - The FDA's Sentinel Innovation Center created a quality-checked network using electronic health records (EHRs) and insurance claims data from over 10 million individuals to enhance regulatory decision-making with real-world data.
- - The resulting network, called the Real-World Evidence Data Enterprise (RWE-DE), includes data from two commercial sources covering 21 million lives and four academic partners covering 4.5 million lives.
- - The report details data completeness, patient populations, and a process for managing free-text notes, while also highlighting potential use cases for RWE-DE to address broader questions in healthcare regulation.