Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control

Project Title Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control
Date Posted
Thursday, March 21, 2019
Status
In progress
Description

This activity is the second 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 objective of this methods activity is to determine whether there is evidence of residual confounding in the association between influenza antiviral(s) and influenza complications in observational studies.

The Sentinel Operations Center (SOC), with guidance from the workgroup, which includes FDA members, will compare study results to estimates derived from randomized controlled clinical trials, with the goal of replicating the known association shown in clinical trials. Second, the SOC will conduct analyses using a negative control period as well as a negative control endpoint to evaluate its analysis model.

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 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

Wendy Carter DO; Division of Anti-Viral Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring MD

Phyo T. Htoo MBBS, MPH; Justin Bohn ScD, ScM; Darren Toh ScD; 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
oseltamivir
Health Outcome
all-cause hospitalization
pneumonia
respiratory antibiotic use
Population / Cohort
Individuals with influenza-like illness
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