Empirical Application of the Sentinel Electronic Health Record (EHR) and Claims Data Partner Network to Address ARIA Insufficient Inferential Requests In progress 11/17/2023
Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development Protocol in preparation 11/17/2023
Characterization of COVID-19 Vaccination Data in the SDD In progress 10/25/2023
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
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 In progress 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
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
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
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