Methods

Sentinel develops a wide range of methods to enhance medical product safety assessment. Early stage methods projects represent truly novel ideas and innovations that require completion of proof-of-concept work. Mid-stage methods projects focus on methodological techniques that have already been shown to be valuable statistically or epidemiologically, but have not been fully applied in the Sentinel Distributed Database (SDD). Later-stage methods projects use a prototype to inform the development, implementation, and enhancement of production-ready analytic tools.  

Title Status Date Postedsort ascending
Mini-Sentinel: Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete 04/22/2014
Mini-Sentinel: Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete 03/13/2014
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete 01/29/2014
Mini-Sentinel: Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete 01/14/2014
Mini-Sentinel: Vaccine Safety Monitoring - Data Characterization Complete 12/27/2013
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3 Complete 11/20/2013
Mini-Sentinel: Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete 10/11/2013
Vaccine Safety Monitoring - Adverse Events Complete 08/28/2013
Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results Complete 01/27/2013
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete 01/24/2013
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 01/11/2013
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/04/2012
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete 04/09/2012
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 03/07/2012
Mini-Sentinel: Case-Based Methods Complete 10/04/2011
Mini-Sentinel: Signal Evaluation Methods (Automated) Complete 08/17/2011
Mini-Sentinel: Sequential Testing Methods Complete 08/11/2011
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 1 Complete 11/11/2010