Stages of Methods Projects

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 Common Data Model (SCDM).
  • Later-stage methods projects use a prototype to inform the development, implementation, and enhancement of production-ready analytic tools.  

Search Methods

Title Status Date
Real World Evidence (RWE): COVID-19 Data Resource Implementation: Sentinel Common Data Model (version 7.1.0) and Rapid COVID-19 Sentinel Distributed Database In progress09/14/2020
Sequential TreeScan Methods Development Complete08/26/2020
Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study In progress08/18/2020
Pilot Test of Vital Signs and Laboratory Results Table Descriptive Modules in the Sentinel Distributed Database In progress07/30/2020
Enhancing Causal Inference in the Sentinel System: An Evaluation of Targeted Learning and Propensity Scores for Confounding Control in Drug Safety In progress07/24/2020
HCA COVID-19 Activities: Monitoring of Critical Drugs and Assessment of Natural History of Disease In progress07/23/2020
TreeScan in Pregnancy In progress06/19/2020
Descriptive Assessment of Coagulopathy Among COVID-19 Patients in the Inpatient Setting: A Sentinel Feasibility Study In progress06/17/2020
Master Protocol Development: COVID-19 Natural History In progress06/05/2020
TriNetX Rapid Querying In progress06/05/2020
Validation of Hospitalized COVID-19 Detected from Claims-Based Algorithms In progress06/01/2020
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET) Complete05/15/2020
Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19 In progress04/20/2020
Horizon Scan of Electronic Health Record Databases In progress04/07/2020
Effects of Medical Products on Suicidal Ideation and Behavior In progress03/02/2020
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery Complete02/29/2020
Application of TreeScan Data Mining Method to HPV9 (Gardasil 9) Vaccine Complete09/03/2019
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities Complete06/27/2019
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments Complete05/29/2019
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics Complete05/24/2019
Development of a Chart Validation Table In progress05/02/2019
Validation of Acute Pancreatitis Using Machine Learning and Multi-Site Adaptation for Anaphylaxis In progress04/30/2019
Investigation of Nonproprietary Name Suffix Use for Biologics and Biosimilars In progress04/24/2019
Characteristics of Patients Using Anti-Diabetic Agents in the Patient-Centered Clinical Research Network (PCORnet): An Exploratory Query of a Network of Electronic Health Records Complete03/26/2019
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control In progress03/21/2019
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete12/14/2018
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses Complete12/05/2018
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest In progress11/14/2018
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete10/30/2018
Validation of Anaphylaxis Using Machine Learning In progress10/11/2018
Cross-Network Directory Service Complete09/17/2018
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data In progress09/14/2018
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Complete08/17/2018
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete08/15/2018
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) In progress07/18/2018
Functional Specifications for Propensity Score Table 1 Complete07/11/2018
Disease Risk Score Exploratory Methods Complete06/26/2018
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete06/21/2018
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete04/27/2018
Sentinel Medical Chart Review Gap Analysis Complete04/18/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete03/27/2018
Optimal Propensity Score Matching Strategies for Subgroup Analyses Complete03/15/2018
Mini-Sentinel: Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete03/07/2018
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case Complete03/06/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete03/05/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins Complete02/23/2018
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case Complete02/12/2018
Conversion of Medicare Claims Synthetic Public Use Files (SynPUFs) to Sentinel Common Data Model (SCDM) Format Complete01/25/2018
Methotrexate Medication Errors Complete12/31/2017
TreeScan Extension (PRISM) Complete12/22/2017
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete11/20/2017
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress08/24/2017
Evaluating Variability with 1:1 Propensity Score-Matched Analyses Complete08/18/2017
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring Complete08/18/2017
Death Data Exploration Complete08/17/2017
Evaluation of New Technologies Associated with Chart Review Complete08/16/2017
Quantitative Bias Analysis Methodology Development Complete08/04/2017
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide Complete07/18/2017
TreeScan for Drugs In progress06/26/2017
TreeScan with Propensity Scores Complete06/26/2017
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete06/15/2017
Developing Disease Risk Score Estimation Functional Specification In progress06/15/2017
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 Complete06/15/2017
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema Complete06/15/2017
TreeScan Power (PRISM) Complete06/12/2017
Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance Complete04/12/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete02/14/2017
Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA’s Sentinel Program Complete10/04/2016
Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete09/30/2016
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angiotensin-Converting Enzyme (ACE) Inhibitors Versus Beta-blockers Complete08/22/2016
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete07/22/2016
Mini-Sentinel: Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete04/27/2016
Mini-Sentinel: Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products Complete04/24/2016
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 Complete04/07/2016
Mini-Sentinel: Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete11/04/2015
Mini-Sentinel: Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database Complete10/13/2015
Mini-Sentinel: Analytical Methods to Assess Robustness of Drug Safety Monitoring Results Complete09/04/2015
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete11/13/2014
Mini-Sentinel: 15 Cohorts of Interest for Surveillance Preparedness Complete05/07/2014
Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database Complete04/23/2014
Mini-Sentinel: Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete04/22/2014
Mini-Sentinel: Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete03/13/2014
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete01/29/2014
Mini-Sentinel: Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete01/14/2014
Mini-Sentinel: Vaccine Safety Monitoring - Data Characterization Complete12/27/2013
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3 Complete11/20/2013
Mini-Sentinel: Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete10/11/2013
Vaccine Safety Monitoring - Adverse Events Complete08/28/2013
Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results Complete01/27/2013
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete01/24/2013
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete01/11/2013
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete12/04/2012
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete04/09/2012
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete03/07/2012
Mini-Sentinel: Case-Based Methods Complete10/04/2011
Mini-Sentinel: Signal Evaluation Methods (Automated) Complete08/17/2011
Mini-Sentinel: Sequential Testing Methods Complete08/11/2011
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 1 Complete11/11/2010
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