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Mini-Sentinel: Case-Based Methods

Basic Details
Date Posted
Status
Complete
Description

Methods project to consider case-based approaches in assessing medical product safety, including case-crossover, case-time control, self-controlled case series, and Bayesian hierarchical extensions across outcomes.

Deliverable(s) (1)
Mini-Sentinel Methods Case-Based Report
Related Links
Related Link(s)
When Should Case-Only Designs be used for Safety Monitoring of Medical Products?
Workgroup Leader(s)

David Madigan, PhD; Columbia University, Department of Statistics, New York, NY

Workgroup Member(s)

Malcolm Maclure, SD, SM; University of British Columbia, Anesthesiology, Pharmacology and Therapeutics Department, Vancouver, BC, Canada

Bruce Fireman, MA; Kaiser Permanente Northern California, Oakland, CA

Wei Hua, MD, PhD; Azadeh Shoaibi, PhD, MHS; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Jennifer Nelson, PhD; Group Health Research Institute, Seattle WA

Antonio Paredes, PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Shawn Simpson, PhD; Columbia University, Department of Statistics, New York, NY