ArticleDrug safety2016
Good Signal Detection Practices: Evidence from IMI PROTECT.
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 83 papers, 1 of them a synthesis that pooled it.
What it found
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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
83 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review.Pharmacoepidemiology and drug safety · 2023Pooled it
- Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.Lancet (London, England) · 2024Trial
- Formulation-Specific Safety Issues of HIV Pre-exposure Prophylaxis Drugs: A Disproportionality Analysis of the FAERS Database.Clinical drug investigation · 2026Article
- Safety Signals of GLP-1 Receptor Agonists: A Multi-Method Pharmacovigilance Analysis of FAERS (2018-2025) With Sensitivity-Stratified Prioritisation, Notoriety-Bias Assessment, and Cross-Database Validation.Diabetes, obesity & metabolism · 2026Article
- Contrastive learning of adverse events to provide effective and interpretable vector representations for machine-assisted pharmacovigilance.Briefings in bioinformatics · 2026Article
- A Feasibility Assessment of the FDA Adverse Event Reporting System for the Detection of Cannabis-Related Safety Signals.Pharmacoepidemiology and drug safety · 2026Article
- Evaluating COVID-19 Vaccine Masking and Unmasking Methods in Two National Pharmacovigilance Databases.Drug safety · 2026Article
- Evaluating adverse events reported for non-steroidal anti-inflammatory drugs in osteoarthritis: a real-world pharmacovigilance study.Inflammopharmacology · 2026Article
- Charting and Sidestepping the Pitfalls of Disproportionality Analysis.Drug safety · 2026Review
- Drug-associated insomnia and sex-specific disproportionality in the FDA adverse event reporting system (2019-Q1 2025).Frontiers in pharmacology · 2026Article
- Peripheral nervous system safety signals of antibody-drug conjugates: cross-database reproducibility and labeling gaps identified using FAERS, JADER, and CVARD.Frontiers in pharmacology · 2026Article
- Article
- Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials.Drug safety · 2025Article
- Article
- Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information.Therapeutic innovation & regulatory science · 2025Article
- Exploring the complexities of disproportionality analysis in pharmacovigilance: reflections on the READUS-PV guideline and a call to action.Frontiers in pharmacology · 2025Article
- Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase).Human reproduction open · 2025Article
- Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.Drug safety · 2024Article
- Global Burden of Vaccine-Associated Chronic Urticaria, 2010-2023: From the Global Pharmacovigilance Database.Allergy, asthma & immunology research · 2024Article
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
23 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
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. The results of studies conducted into quantitative signal detection in spontaneous reporting, clinical trial and electronic health records databases are summarised and 39 recommendations have been formulated, many based on comparative analyses across a range of databases (e.g. regulatory, pharmaceutical company). The recommendations point to pragmatic steps that those working in the pharmacovigilance community can take to improve signal detection practices, whether in a national or international agency or in a pharmaceutical company setting. PROTECT has also pointed to areas of potentially fruitful future research and some areas where further effort is likely to yield less.
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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.