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Updated: Jan 8, 2026

Feeding Experimentation Device FED: Construction and Validation of an Open-source Device for Measuring Food Intake in Rodents

Feeding Experimentation Device FED: Construction and Validation of an Open-source Device for Measuring Food Intake in Rodents

Published on: February 21, 2017

FDA Sentinelイニシアチブにおける推論研究の強化：方法論的実証プロジェクトの結果

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.

NPJ digital medicine

|December 15, 2025

Abstract:

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.

キーワード:

FDA Sentinel Real-world evidence Comparative effectiveness research Pharmacovigilance Type 2 diabetes mellitus Sodium-glucose cotransporter-2 inhibitors Dipeptidyl peptidase-4 inhibitors Acute pancreatitis

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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Published on: January 27, 2014

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