ReviewPharmacoepidemiology and drug safety2021
A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.
Review in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
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
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Adverse outcomes among pregnant women with COVID-19 according to hospitalization status: A prospective individual participant data meta-analysis in Europe and North America.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Pooled it
- Sequential Safety Surveillance of RSVpreF Vaccination During Pregnancy Early in the Postapproval Period.JAMA network open · 2026Article
- Association Between Race and COVID-19 Outcomes During the Pre-Vaccination Period in the United States (2020-2021).Clinical epidemiology · 2026Article
- Active surveillance for the safety and effectiveness of health products for COVID-19: a scoping review.Frontiers in pharmacology · 2026Article
- Twenty-Five Years of Evolution and Hurdles in Electronic Health Records and Interoperability in Medical Research: Comprehensive Review.Journal of medical Internet research · 2025Review
- Advancing pediatric medication safety using real-world data: Current problems and potential solutions.Journal of hospital medicine · 2023Article
- Mobile Health Study Incorporating Novel Fitness Test.Journal of cardiovascular translational research · 2023Article
- Coronavirus Disease 2019 Severity and Risk of Subsequent Cardiovascular Events.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Assessment and Improvement of Drug Data Structuredness From Electronic Health Records: Algorithm Development and Validation.JMIR medical informatics · 2023Article
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- Article
- The US Food and Drug Administration Sentinel System: a national resource for a learning health system.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- Article
- COVID-19 pharmacotherapy utilization patterns during pregnancy: International Registry of Coronavirus Exposure in Pregnancy.Pharmacoepidemiology and drug safety · 2022Observational
- Categorization of COVID-19 severity to determine mortality risk.Pharmacoepidemiology and drug safety · 2022Article
- Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources.Drug safety · 2022Review
- Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.JAMA cardiology · 2022Article
- Applying Machine Learning in Distributed Data Networks for Pharmacoepidemiologic and Pharmacovigilance Studies: Opportunities, Challenges, and Considerations.Drug safety · 2022Review
- Using inpatient electronic medical records to study influenza for pandemic preparedness.Influenza and other respiratory viruses · 2022Article
- SARS-CoV-2 Pandemic and Food Safety Oversight: Implications in Canada and Coping Strategies.Foods (Basel, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 4 institutions in 1 country.
Funding
Abstract
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.
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.