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Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET)

Basic Details
Date Posted
Status
Complete
Medical Product
influenza antiviral
Health Outcome(s)
ordinal endpoints in the inpatient setting, e.g., intensive care unit hospitalization with and without ventilation or ECMO and in-hospital death
Description

This activity is the first project sponsored by the FDA Office of the Chief Scientist (OCS), Office of Counterterrorism and Emerging Threats (OCET) to explore how the Sentinel System may inform study protocols for medical countermeasure safety and effectiveness and to provide a valuable baseline for comparison during a public health emergency. The Sentinel Distributed Database (SDD) will be queried to determine the feasibility of capturing meaningful ordinal endpoints for a subset of patients, using an influenza scenario to serve as a proxy for public health emergency events. The populations of interest will include individuals with influenza-like illness, pneumonia and influenza, or medically attended acute respiratory illness during 3-5 prior influenza seasons.

Information
Population / Cohort
Multiple influenza-like illness and/or pneumonia and influenza cohorts
Related Links
Related Link(s)
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control
OCET Medical Countermeasures Initiative (MCMi)
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET)
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System
Sentinel Drug Analysis: Characterization of Influenza Complications Among Individuals Diagnosed with Influenza‐Like Illness, Pneumonia and Influenza, and Medically Attended Acute Respiratory Illness: A Descriptive Analysis
Workgroup Leader(s)

Noelle Cocoros, DSc, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Gregory Measer, JD; Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring MD

Workgroup Member(s)

Robert Orr; Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD

Henry "Skip" Francis, MD; Alfred Sorbello, DO, MPH; Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Sarah Dutcher, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Catherine A. Panozzo, PhD; Crystal Garcia, MPH; Nicole R. Haug, MPH, Austin Cosgrove; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA