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

Project Title Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET)
Date Posted
Wednesday, July 18, 2018
Status
In progress
Description

This activity is the first project sponsored by the FDA 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 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.

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; Jean Hu-Primmer MS; 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 Members

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 BS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Medical Product
neuraminidase inhibitors
Health Outcome
ordinal endpoints in the inpatient setting, e.g., intensive care unit hospitalization with and without ventilation or ECMO and in-hospital death
Population / Cohort
Multiple influenza-like illness and/or pneumonia and influenza cohorts
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