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
Application of TreeScan Data Mining Method to HPV9 (Gardasil 9) Vaccine Complete 09/03/2019
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities Complete 06/27/2019
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments Complete 05/29/2019
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics In progress 05/24/2019
Development of a Chart Validation Table In progress 05/02/2019
Validation of Acute Pancreatitis Using Machine Learning and Multi-Site Adaptation for Anaphylaxis In progress 04/30/2019
Investigation of Nonproprietary Name Suffix Use for Biologics and Biosimilars In progress 04/24/2019
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery In progress 04/24/2019
Characteristics of Patients Using Anti-Diabetic Agents in the People-Centered Research Foundation (PCRF): An Exploratory Query of a Network of Electronic Health Records In progress 03/26/2019
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control In progress 03/21/2019
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete 12/14/2018
Sequential TreeScan Signal Identification Methods Development In progress 12/11/2018
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses Complete 12/05/2018
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest In progress 11/14/2018
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete 10/30/2018
Validation of Anaphylaxis Using Machine Learning In progress 10/11/2018
Cross-Network Directory Service Complete 09/17/2018
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data In progress 09/14/2018
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Complete 08/17/2018
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) In progress 07/18/2018
Functional Specifications for Propensity Score Table 1 Complete 07/11/2018
Disease Risk Score Exploratory Methods Complete 06/26/2018
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete 06/21/2018
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete 04/27/2018
Sentinel Medical Chart Review Gap Analysis Complete 04/18/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete 03/27/2018
Optimal Propensity Score Matching Strategies for Subgroup Analyses Complete 03/15/2018
Mini-Sentinel: Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete 03/07/2018
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case Complete 03/06/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete 03/05/2018
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
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case Complete 02/12/2018
Conversion of Medicare Claims Synthetic Public Use Files (SynPUFs) to Sentinel Common Data Model (SCDM) Format Complete 01/25/2018
Methotrexate Medication Errors Complete 12/31/2017
TreeScan Extension (PRISM) Complete 12/22/2017
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete 11/20/2017
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress 08/24/2017
Evaluating Variability with 1:1 Propensity Score-Matched Analyses Complete 08/18/2017
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring Complete 08/18/2017
Death Data Exploration Complete 08/17/2017
Evaluation of New Technologies Associated with Chart Review Complete 08/16/2017
Quantitative Bias Analysis Methodology Development Complete 08/04/2017
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide Complete 07/18/2017
TreeScan for Drugs In progress 06/26/2017
TreeScan with Propensity Scores Complete 06/26/2017
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete 06/15/2017
Developing Disease Risk Score Estimation Functional Specification In progress 06/15/2017
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 Complete 06/15/2017
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema In progress 06/15/2017
TreeScan Power (PRISM) Complete 06/12/2017
Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance Complete 04/12/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 02/14/2017
Developments, Applications, and Methodological Challenges to the use of Propensity Score Matching Approaches in FDA’s Sentinel Program Complete 10/04/2016
Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 09/30/2016
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angiotensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers Complete 08/22/2016
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete 07/22/2016
Mini-Sentinel: Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete 04/27/2016
Mini-Sentinel: Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products Complete 04/24/2016
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 04/07/2016
Mini-Sentinel: Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete 11/04/2015
Mini-Sentinel: Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database Complete 10/13/2015
Mini-Sentinel: Analytical Methods to Assess Robustness of Drug Safety Monitoring Results Complete 09/04/2015
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete 11/13/2014
Mini-Sentinel: 15 Cohorts of Interest for Surveillance Preparedness Complete 05/07/2014
Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database Complete 04/23/2014
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