ReviewDrug safety2005
Perspectives on the use of data mining in pharmaco-vigilance.
Review in Drug safety, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 3 of them syntheses 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
93 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.European journal of clinical pharmacology · 2025Pooled it
- Real-world use of nonvitamin K antagonist oral anticoagulant in atrial fibrillation patients with liver disease: A meta-analysis.Clinical cardiology · 2020Pooled it
- Psychiatric Safety Signals of GLP-1 Receptor Agonists: A FAERS-Based Pharmacovigilance Study with Explainable Machine Learning.Pharmaceuticals (Basel, Switzerland) · 2026Article
- A Feasibility Assessment of the FDA Adverse Event Reporting System for the Detection of Cannabis-Related Safety Signals.Pharmacoepidemiology and drug safety · 2026Article
- Article
- Drug-Induced Raynaud's Phenomenon and Underlying Mechanism: A Disproportionality Analysis From the World Health Organization Pharmacovigilance Database.Arthritis & rheumatology (Hoboken, N.J.) · 2026Article
- Indication-specific adverse event profiles of semaglutide and liraglutide: a FAERS disproportionality analysis.Frontiers in pharmacology · 2026Article
- Adverse events related to drug-drug interactions in tocilizumab combination therapy: a retrospective analysis and clinical implications.Frontiers in medicine · 2026Article
- Development and validation of a MedDRA-based signal detection construct for drug-induced neurobehavioral impairment.Therapeutic advances in drug safety · 2026Article
- Prescribed Drugs and Interpersonal Violence: A Case-Non-Case Study in the Spanish Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.Pharmacoepidemiology and drug safety · 2025Review
- Pharmacovigilance analysis of orlistat adverse events based on the FDA adverse event reporting system (FAERS) database.Heliyon · 2024Article
- Risk of immune system and skin and subcutaneous tissue related adverse events associated with oxaliplatin combined with immune checkpoint inhibitors: a pharmacovigilance study.Frontiers in pharmacology · 2024Article
- Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective.Journal of clinical medicine · 2023Article
- Prescribed Drugs and Self-Directed Violence: A Descriptive Study in the Spanish Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Commentary: Adverse event profiles of PARP inhibitors: analysis of spontaneous reports submitted to FAERS.Frontiers in pharmacology · 2023Article
- Signaling COVID-19 Vaccine Adverse Events.Drug safety · 2022Article
- Vaccine Adverse Event Mining of Twitter Conversations: 2-Phase Classification Study.JMIR medical informatics · 2022Article
- Social Media Analytics for Pharmacovigilance of Antiepileptic Drugs.Computational and mathematical methods in medicine · 2022Article
33 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmaco-vigilance. In 2003, a group of statisticians, pharmaco-epidemiologists and pharmaco-vigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmaco-vigilance methods. Perspectives from both the FDA and the industry are provided. Data mining is a potentially useful adjunct to traditional pharmaco-vigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.
Indexed as
Identifiers
16231953What 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.