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
Quantitative Bias Analysis Methodology Development Complete 8/4/2017
Comparison of safety signaling methods for survival outcomes to control for confounding in the MSDD – Phase 2 In progress 6/29/2017
TreeScan for Drugs In progress 6/26/2017
TreeScan with Propensity Scores In progress 6/26/2017
Chart Review Gap Analysis In progress 6/15/2017
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case In progress 6/15/2017
Disease Risk Score Exploratory Methods In progress 6/15/2017
Developing Disease Risk Score Estimation Functional Specification In progress 6/15/2017
Identification of Pregnant Women in the Sentinel Distributed Database and Determination of Drug Use Among Pregnant and Non-Pregnant Women – ICD-10-CM Pregnancy Tool Algorithm Update In progress 6/15/2017
Optimal Propensity Score Matching Strategies for Subgroup Analyses In progress 6/15/2017
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema In progress 6/15/2017
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments In progress 6/15/2017
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative In progress 6/15/2017
Sequential Surveillance for Drug Safety in a Regulatory Environment In progress 6/15/2017
Enhancing TreeScan for Long-Term Follow-up In progress 6/15/2017
Analytic Methods for Using Laboratory Test Results In Active Database Surveillance Complete 4/13/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 2/14/2017
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel In progress 12/12/2016
Developments, Applications, And Methodological Challenges to The Use Of Propensity Score Matching Approaches In FDA’s Sentinel Program Complete 10/4/2016
Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 9/29/2016
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete 7/22/2016
Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete 4/27/2016
Routine prospective safety surveillance for new drugs, vaccines, and other biologic products Complete 4/25/2016
Validating Type 1 and Type 2 Diabetes Mellitus in the Mini-Sentinel Distributed Database using the Surveillance PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) DataLink Complete 4/7/2016
Testing routine querying tools with known positive exposure-outcome associations In progress 1/31/2016
Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete 11/4/2015
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database In progress 10/27/2015
Safety Signaling Methods for Survival Outcomes to Control for Confounding in the MSDD Complete 10/13/2015
Analytical Methods to Assess Robustness of Drug Safety Monitoring Results Complete 9/4/2015
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program In progress 6/10/2015
TreeScan Power (PRISM) In progress 11/13/2014
TreeScan Extension (PRISM) In progress 11/13/2014
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete 11/13/2014
15 Cohorts of Interest for Surveillance Preparedness Complete 5/7/2014
Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database Complete 4/23/2014
Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete 4/22/2014
Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete 3/13/2014
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete 1/29/2014
Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete 1/14/2014
Taxonomy of Observational Study Designs – Phase 3 Complete 11/20/2013
Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete 10/11/2013
Framework for Assessment of Signal Refinement Positive Results Complete 1/27/2013
Methods to Evaluate Impact of FDA Regulatory Actions Complete 1/24/2013
Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 1/11/2013
Re-use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/5/2012
Taxonomy of Observational Study Designs – Phase 2 Complete 4/9/2012
Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 3/7/2012
Case-Based Methods Complete 10/4/2011
Signal Evaluation Methods (Automated) Complete 8/17/2011
Sequential Testing Methods Complete 8/11/2011
Vaccine Safety Monitoring - Adverse Events In progress 11/15/2010
Taxonomy of Observational Study Designs - Phase 1 Complete 11/11/2010