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Stages of Methods Projects

Sentinel develops a wide range of methods to enhance medical product safety assessment.

Early Stage Methods Projects

Early stage methods projects represent truly novel ideas and innovations. They require completion of proof-of-concept work.

Mid-Stage Methods Projects

Mid-stage methods projects focus on methodological techniques showing statistical or epidemiological value. But, they have not been fully applied in the Sentinel Common Data Model (SCDM).

Later Stage Methods Projects

Later stage methods projects create a prototype to inform production-ready analytic tools.

Interested in learning more about methods? Below is a full list of Sentinel's methods.

Search Methods Projects

Title Status Date
Characterization of COVID-19 Genomic Data in Sentinel Distributed Database Complete 08/18/2023
Effectiveness of Fixed Triple Combination Inhaled Corticosteroid (ICS), Long-Acting Beta-Agonist (LABA), and Long-Acting Muscarinic Antagonist (LAMA) Products vs. Multiple Inhaler ICS, LABA, LAMA Therapy in Patients With COPD Protocol in preparation 07/31/2023
Data Expansion Implementation: Linking the National Death Index (NDI) data to the Sentinel Distributed Database (SDD) In progress 06/01/2023
Subset Calibration Methods In progress 05/08/2023
Creating a Sentinel Linked Electronic Health Record (EHR)-claims Development Network In progress 04/18/2023
Medical Literature and Data on Cannabis Use Complete 02/23/2023
Development and Evaluation of Electronic Health Record (EHR) Information Extraction Pipeline and Tree-Based Scan Statistic (TBSS) Methods for EHR-Based Signal Detection (DA2) In progress 01/27/2023
Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development Protocol in preparation 12/13/2022
Inclusion of Semi-Structured and Unstructured Electronic Health Record (EHR) Data in Confounding Adjustment and Outcome Ascertainment In progress 12/09/2022
Onboarding of Commercial Electronic Health Record (EHR) Data Partners In progress 11/01/2022
Data Sandbox and Engagement Environment Discovery Project Complete 09/07/2022
Approaches to Handling Partially Observed Confounder Data From Electronic Health Records (EHR) In Non-randomized Studies of Medication Outcomes Protocol in preparation 06/01/2022
Augmenting Date of Death & Cause of Death Ascertainment in Sentinel In progress 03/16/2022
Sentinel Innovation Center Request for Proposal: Feature Engineering Complete 03/15/2022
Improving Capture of Race and Ethnicity Data in Sentinel Complete 03/08/2022
Development and Illustration of a Framework for Conducting Nonrandomized Studies of Medication Safety and Effectiveness Using Healthcare Databases In progress 12/10/2021
Identification and Mitigation of Structured Electronic Health Record (EHR) Source Data Mapping Issues Complete 11/24/2021
Evaluation of Existing Approaches to EHR-based Signal Identification Complete 11/19/2021
Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs In progress 09/24/2021
Longitudinal Trends in Incident and Prevalent use of Long-Acting Beta-2 Agonists: An Interrupted Time Series Analysis Complete 08/24/2021
Develop a Common Protocol for Data Quality Metrics in Electronic Health Records Complete 08/18/2021
Using Unsupervised Learning to Harmonize Data Across Data Systems In progress 07/28/2021
Representation of Unstructured Data Across Common Data Models Complete 07/14/2021
TreeScan in Pregnancy In progress 07/14/2021
Improving Probabilistic Phenotyping of Incident Outcomes through Enhanced Ascertainment with Natural Language Processing In progress 05/20/2021
Demographic Characteristics and Length of Enrollment of the Individuals Enrolled over Time in the Sentinel Distributed Database Complete 05/17/2021
Extending Machine Learning Methods Development in Sentinel: Follow-up Analyses for Anaphylaxis Algorithm and Formalization of a General Phenotyping Framework (Phase 3) In progress 05/17/2021
Advancing Scalable Natural Language Processing Approaches for Unstructured Electronic Health Record Data In progress 02/26/2021
COVID-19 Pregnancy Study Implementation In progress 02/24/2021
Incidence of Latent Tuberculosis Infection: A Descriptive Analysis Complete 02/12/2021
A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy Complete 10/29/2020
Assessment of the Natural History of Coagulopathy in COVID-19 In progress 10/21/2020
Master Protocol Development: COVID-19 Natural History Complete 10/13/2020
Addition of COVID Laboratory Results Data to the Sentinel Common Data Model (SCDM) and Establishment of a “Freshest Feasible” Rapid COVID-19 Data Resource In progress 09/14/2020
Sequential TreeScan Methods Development Complete 08/26/2020
Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study Complete 08/18/2020
Pilot Test of Vital Signs and Laboratory Results Table Descriptive Modules in the Sentinel Distributed Database Complete 07/30/2020
Enhancing Causal Inference in the Sentinel System: An Evaluation of Targeted Learning and Propensity Scores for Confounding Control in Drug Safety In progress 07/24/2020
HCA COVID-19 Activities: Monitoring of Critical Drugs and Assessment of Natural History of Disease In progress 07/22/2020
TriNetX Rapid Querying Complete 06/05/2020
Validation of Hospitalized COVID-19 Detected from Claims-Based Algorithms Complete 05/31/2020
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET) Complete 05/14/2020
Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19 In progress 04/20/2020
Horizon Scan of Electronic Health Record Databases Complete 04/07/2020
Effects of Medical Products on Suicidal Ideation and Behavior Complete 03/02/2020
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery Complete 02/29/2020
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 Complete 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 Complete 04/30/2019
Investigation of Nonproprietary Name Suffix Use for Biologics and Biosimilars In progress 04/24/2019
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 Complete 03/26/2019
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control Complete 03/21/2019
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete 12/14/2018
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses Complete 12/05/2018
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest Complete 11/13/2018
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 Complete 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) Complete 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 Complete 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 Complete 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
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete 01/24/2013
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 01/11/2013
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/04/2012
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete 04/09/2012
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 03/07/2012
Mini-Sentinel: Case-Based Methods Complete 10/04/2011
Mini-Sentinel: Signal Evaluation Methods (Automated) Complete 08/17/2011
Mini-Sentinel: Sequential Testing Methods Complete 08/11/2011
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 1 Complete 11/11/2010