Details
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.
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
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