ArticleJournal of the American Medical Informatics Association : JAMIA2022
The US Food and Drug Administration Sentinel System: a national resource for a learning health system.
Article in Journal of the American Medical Informatics Association : JAMIA, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 37 citations in OpenAlex.
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- Augmenting Medical Judgment in Signal Confirmation: Design Considerations for an AI-Enabled Causality Assessment Framework.Drug safety · 2026Review
- US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008-2022).Drug safety · 2026Article
- Alignment of Policy, Practice, and Patient Safety for Trustworthy AI in Radiology.Radiology. Artificial intelligence · 2026Article
- The Claims Data Learning & Enhancing for Algorithm Refinement (CLEAR) Study: Overview of the Study Design and Baseline Profile.Journal of epidemiology · 2026Article
- Secure distributed multiple imputation enables missing data inference for private data proprietors.NPJ digital medicine · 2026Article
- Generative Transformers for Pharmacovigilance Signal Detection using Electronic Health Records.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2026Article
- Review
- Association Discovery Approach in Healthcare Big Data to Identify Drug Safety and Drug Repurposing Signals.Clinical pharmacology and therapeutics · 2026Article
- Crossing borders securely: synthetic data and federated networks for privacy-preserving access to real-world data and emerging use cases.NPJ digital medicine · 2025Review
- A Review of the Importance and Relevance of Real-World Data and Real-World Evidence.Medical science monitor : international medical journal of experimental and clinical research · 2025Review
- Article
- Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?Drug safety · 2025Article
- Core Concepts in Pharmacoepidemiology: Multi-Database Distributed Data Networks.Pharmacoepidemiology and drug safety · 2025Review
- Article
- A future of data-rich pharmacoepidemiology studies: transitioning to large-scale linked electronic health record + claims data.American journal of epidemiology · 2025Article
- Achieving a rapid and continuous learning health system requires socio-technical harmonization of research and operational IT.npj health systems · 2025Review
- US public health surveillance, reimagined.Learning health systems · 2024Article
- Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration.Journal of medical Internet research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 1 country.
Funding
Abstract
The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. The Sentinel System has completed hundreds of analyses, including many that have directly informed regulatory decisions. The Sentinel System also was designed to support a national infrastructure for a learning health system. Sentinel governance and guiding principles were designed to facilitate Sentinel's role as a national resource. The Sentinel System infrastructure now supports multiple non-FDA projects for stakeholders ranging from regulated industry to other federal agencies, international regulators, and academics. The Sentinel System is a working example of a learning health system that is expanding with the potential to create a global learning health system that can support medical product safety assessments and other research.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.