Details
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.
Additional Information
Contributors
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
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