Statistical Methods Development

Statistical methods development projects focus on determining how well existing statistical methods work for Mini-Sentinel activities and whether new statistical methods yield more accurate results.

The following table provides summary information concerning reports about Mini-Sentinel statistical methods development that have been prepared for the FDA by Mini-Sentinel collaborators as part of this pilot. Please click on the details link for additional information.

 

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Results from Statistical Methods Development Search
 TitleStatusDate Posted
DetailsFramework for Assessment of Signal Refinement Positive ResultsComplete 1-28-2013
DetailsMethods to Evaluate Impact of FDA Regulatory ActionsComplete 1-24-2013
DetailsEvaluating Strategies for Data Sharing and Analyses in Distributed Data SettingsComplete 1-11-2013
DetailsRe-use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular ProgramsComplete 12-06-2012
DetailsTaxonomy of Observational Study Designs – Phase 2Complete 4-11-2012
DetailsStatistical Methods for Estimating Causal Risk Differences (PRISM)Complete 3-08-2012
DetailsCase-Based MethodsComplete 10-04-2011
DetailsSignal Evaluation Methods (Automated) Complete 8-17-2011
DetailsSequential Testing MethodsComplete 8-11-2011
DetailsVaccine Safety Monitoring - Adverse EventsIn progress 11-16-2010
DetailsTaxonomy of Observational Study Designs - Phase 1Complete 11-12-2010