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

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.