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.  

Titlesort descending Status Date Posted
15 Cohorts of Interest for Surveillance Preparedness Complete 05/07/2014
Analytic Methods for Using Laboratory Test Results in Active Database Surveillance Complete 04/12/2017
Analytical Methods to Assess Robustness of Drug Safety Monitoring Results Complete 09/04/2015
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses In progress 12/05/2018
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities In progress 12/10/2018
Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete 03/07/2018
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete 06/21/2018
Case-Based Methods Complete 10/04/2011
Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete 01/14/2014
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete 04/27/2018
Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete 03/13/2014
Conversion of Medicare Claims Synthetic Public Use Files (SynPUFs) to Sentinel Common Data Model (SCDM) Format Complete 01/25/2018
Cross-Network Directory Service Complete 09/17/2018
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete 10/30/2018
Death Data Exploration Complete 08/17/2017
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete 11/13/2014
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete 01/29/2014
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) In progress 07/18/2018
Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database Complete 04/23/2014
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case In progress 06/15/2017
Developing Disease Risk Score Estimation Functional Specification In progress 06/15/2017
Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete 10/11/2013
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics In progress 08/10/2018
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete 11/20/2017
Developments, Applications, and Methodological Challenges to the use of Propensity Score Matching Approaches in FDA’s Sentinel Program Complete 10/04/2016
Disease Risk Score Exploratory Methods In progress 06/15/2017
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete 12/14/2018
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete 06/15/2017
Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 01/11/2013
Evaluating Variability with 1:1 Propensity Score-Matched Analyses In progress 08/18/2017
Evaluation of New Technologies Associated with Chart Review Complete 08/16/2017
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments In progress 06/15/2017
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery In progress 11/30/2018
Framework for Assessment of Signal Refinement Positive Results Complete 01/27/2013
Functional Specifications for Propensity Score Table 1 Complete 07/11/2018
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 Complete 06/15/2017
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel In progress 12/12/2016
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete 07/22/2016
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress 08/24/2017
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest In progress 11/15/2018
Methods to Evaluate Impact of FDA Regulatory Actions Complete 01/24/2013
Methotrexate Medication Errors In progress 08/17/2017
Optimal Propensity Score Matching Strategies for Subgroup Analyses In progress 06/15/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 02/14/2017
Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 09/30/2016
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema In progress 06/15/2017
Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete 11/04/2015
Quantitative Bias Analysis Methodology Development Complete 08/04/2017
Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/04/2012
Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products Complete 04/24/2016
Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database Complete 10/13/2015
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case In progress 09/15/2017
Sentinel Medical Chart Review Gap Analysis Complete 04/18/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete 03/05/2018
Sequential Testing Methods Complete 08/11/2011
Sequential TreeScan Signal Identification Methods Development In progress 12/11/2018
Signal Evaluation Methods (Automated) Complete 08/17/2011
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data In progress 09/14/2018
Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 03/07/2012
Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete 04/22/2014
Taxonomy of Observational Study Designs - Phase 1 Complete 11/11/2010
Taxonomy of Observational Study Designs - Phase 2 Complete 04/09/2012
Taxonomy of Observational Study Designs - Phase 3 Complete 11/20/2013
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angioensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers In progress 01/31/2016
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete 03/27/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins Complete 02/23/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide Complete 07/18/2017
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring In progress 08/18/2017
TreeScan Extension (PRISM) In progress 11/13/2014
TreeScan for Drugs In progress 06/26/2017
TreeScan Power (PRISM) In progress 11/13/2014
TreeScan with Propensity Scores Complete 06/26/2017
Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete 04/27/2016
Vaccine Safety Monitoring - Adverse Events In progress 11/15/2010