ArticleDrug safety2015
Pediatric drug safety signal detection: a new drug-event reference set for performance testing of data-mining methods and systems.
Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Contrastive learning of adverse events to provide effective and interpretable vector representations for machine-assisted pharmacovigilance.Briefings in bioinformatics · 2026Article
- A manufacturer-aware cross-system benchmark for pediatric pharmacovigilance signal concordance.Frontiers in pharmacology · 2026Article
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- OnSIDES database: Extracting adverse drug events from drug labels using natural language processing models.Med (New York, N.Y.) · 2025Article
- Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information.Therapeutic innovation & regulatory science · 2025Article
- Evaluating Triptan Safety in Pediatric Migraine Management: A Comprehensive Pharmacovigilance Analysis.Journal of pain research · 2025Article
- Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia.BMC medical informatics and decision making · 2024Article
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.Paediatric drugs · 2022Review
- A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development.Med (New York, N.Y.) · 2022Article
- No population left behind: Improving paediatric drug safety using informatics and systems biology.British journal of clinical pharmacology · 2022Review
- Evaluating risk detection methods to uncover ontogenic-mediated adverse drug effect mechanisms in children.BioData mining · 2021Article
- From Data Silos to Standardized, Linked, and FAIR Data for Pharmacovigilance: Current Advances and Challenges with Observational Healthcare Data.Drug safety · 2019Article
- Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification.Drug safety · 2016Article
- Medication safety research by observational study design.International journal of clinical pharmacy · 2016Review
- Literature-Based Discovery of Confounding in Observational Clinical Data.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2016Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBetter evidence regarding drug safety in the pediatric population might be generated from existing data sources such as spontaneous reporting systems and electronic healthcare records. The Global Research in Paediatrics (GRiP)-Network of Excellence aims to develop pediatric-specific methods that can be applied to these data sources. A reference set of positive and negative drug-event associations is required.
objectiveThe aim of this study was to develop a pediatric-specific reference set of positive and negative drug-event associations.
methodsConsidering user patterns and expert opinion, 16 drugs that are used in individuals aged 0-18 years were selected and evaluated against 16 events, regarded as important safety outcomes. A cross-table of unique drug-event pairs was created. Each pair was classified as potential positive or negative control based on information from the drug's Summary of Product Characteristics and Micromedex. If both information sources consistently listed the event as an adverse event, the combination was reviewed as potential positive control. If both did not, the combination was evaluated as potential negative control. Further evaluation was based on published literature.
resultsSelected drugs include ibuprofen, flucloxacillin, domperidone, methylphenidate, montelukast, quinine, and cyproterone/ethinylestradiol. Selected events include bullous eruption, aplastic anemia, ventricular arrhythmia, sudden death, acute kidney injury, psychosis, and seizure. Altogether, 256 unique combinations were reviewed, yielding 37 positive (17 with evidence from the pediatric population and 20 with evidence from adults only) and 90 negative control pairs, with the remainder being unclassifiable.
conclusionWe propose a drug-event reference set that can be used to compare different signal detection methods in the pediatric population.
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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.