Related Experiment Video
Updated: Jan 8, 2026

Feeding Experimentation Device FED: Construction and Validation of an Open-source Device for Measuring Food Intake in Rodents
Published on: February 21, 2017
Strengthening inferential studies in the FDA Sentinel initiative: results from a methodological demonstration project
Rishi J Desai1, Janick Weberpals2, Haritha Pillai2
1Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. rdesai@bwh.harvard.edu.
None:
The FDA Sentinel Real-World Evidence Data Enterprise (RWE-DE) contains linked electronic health records with claims data for over 25 million patients. To demonstrate the applicability of the RWE-DE to a study previously considered infeasible in claims-based Sentinel network, we emulated a target trial using a case study comparing acute pancreatitis among new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) with new users of dipeptidyl peptidase-4 inhibitors (DPP-4i) among 97,119 patients with type 2 diabetes mellitus from HealthVerity [2018-2020] and TriNetX [2013-2024] databases. We applied a previously validated computable phenotyping algorithm using EHRs to identify acute pancreatitis as the primary outcome. After confounding adjustment for >135 variables using propensity score fine stratification weighting, the hazard ratio (95% confidence interval) for acute pancreatitis following SGLT-2i initiation compared to DPP-4i initiation was 0.85 (0.67-1.07) for intent-to-treat and 0.84 (0.58-1.22) for per-protocol analysis. This study serves as a proof-of-concept for future safety assessments in Sentinel.
More Related Videos
06:05The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
09:39Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications
Published on: January 27, 2014
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Regulation
Clinical Trials: Overview
Introduction to Epidemiology
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...