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

Basic Details
Date Posted
Thursday, March 21, 2019
Status
Complete
Medical Product
oseltamivir
Health Outcome(s)
all-cause hospitalization
pneumonia
respiratory antibiotic use
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.

Information
Population / Cohort
Individuals with influenza-like illness
Related Links
Related Link(s)
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET)
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)
Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data
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

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