Abstract The US Food and Drug Administration's Sentinel System was established in 2009
to use routinely collected electronic health data for improving the national capability to …

A distributed health data network is a system that allows secure remote analysis of separate
data sets, each comprising a different medical organization's or health plan's records …

Introduction Pharmacovigilance programs protect patient health and safety by identifying
adverse event signals through postmarketing surveillance of claims data and spontaneous …

Background HIV pre-exposure prophylaxis (PrEP) is effective but underused, in part
because clinicians do not have the tools to identify PrEP candidates. We developed and …

OBJECTIVE To estimate real-world off-label use of sodium–glucose cotransporter 2 (SGLT2)
inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and …

Abstract The US Food and Drug Administration (FDA) created the Sentinel System in
response to a requirement in the FDA Amendments Act of 2007 that the agency establish a …

Background Except for spontaneous reporting systems, vaccine safety monitoring generally
involves pre-specifying health outcomes and post-vaccination risk windows of concern …

The tree-based scan statistic is a statistical data mining tool that has been used for signal
detection with a self-controlled design in vaccine safety studies. This disproportionality …

Abstract The US Food and Drug Administration (FDA) Sentinel System uses a distributed
data network, a common data model, curated real-world data, and distributed analytic tools …

The self-controlled tree-temporal scan statistic—a new signal-detection method—can
evaluate whether any of a wide variety of health outcomes are temporally associated with …