Strengthening Inferential Studies in the U.S. FDA Sentinel Initiative: A Methodological Demonstration Project

Health insurance claims data currently form the backbone of the Sentinel Distributed Database (SDD), owing to their complete capture of outpatient pharmacy dispensing records, medical encounters, and hospitalizations during well-defined periods of health plan enrollment. However, due to limitations inherent to claims data, Sentinel’s Active Risk Identification and Analysis (ARIA) system is, at times, deemed insufficient to address a regulatory question of interest, e.g., due to the lack of granular clinical information available. 

In an effort to minimize this occurrence and enhance the SDD, the Sentinel Innovation Center (IC) has undertaken efforts to establish a query-ready, quality-checked distributed data network linking longitudinal electronic health records (EHRs) with claims data for 21 million patients from two large commercial data assets, HealthVerity and TriNetX. 

Through this demonstration project, we aimed to demonstrate the applicability of the FDA Sentinel’s Real World Evidence Data Enterprise (RWE-DE) and the methodological tools developed through different innovation center projects in a use case of the risk of acute pancreatitis following initiation of SGLT2 inhibitors compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) in patients with type 2 diabetes mellitus (T2DM).

This Sentinel Innovation Center (IC) project is led by Mass General Brigham, in collaboration with the Harvard Pilgrim Health Care Institute and Harvard Medical School. This project will utilize data sets prepared by two commercial Data Partners, HealthVerity and TriNetX.