| 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 |