ReviewDrug safety2014
Safety signal detection: the relevance of literature review.
Review in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Impact of literature reports on drug safety signals.Wiener klinische Wochenschrift · 2021Pooled it
- Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.Pharmacoepidemiology and drug safety · 2025Article
- Discovering Severe Adverse Reactions From Pharmacokinetic Drug-Drug Interactions Through Literature Analysis and Electronic Health Record Verification.Clinical pharmacology and therapeutics · 2025Article
- Serotonin syndrome: A pharmacovigilance comparative study of drugs affecting serotonin levels.European journal of clinical pharmacology · 2024Article
- Guiding axes for drug safety management of pharmacovigilance centres during the COVID-19 era.International journal of clinical pharmacy · 2021Article
- Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use.Drug safety · 2020Article
- Hidden Cardiotoxicity of Rofecoxib Can be Revealed in Experimental Models of Ischemia/Reperfusion.Cells · 2020Article
- Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.Pharmaceutical medicine · 2019Article
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- Article
- Toward multimodal signal detection of adverse drug reactions.Journal of biomedical informatics · 2017Article
- Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.Applied clinical informatics · 2017Article
- A curated and standardized adverse drug event resource to accelerate drug safety research.Scientific data · 2016Article
- Analyzing search behavior of healthcare professionals for drug safety surveillance.Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing · 2015Article
- A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.Drug safety · 2014Article
- A time-indexed reference standard of adverse drug reactions.Scientific data · 2014Article
- Pharmacovigilance: empowering healthcare professionals and patients.International journal of clinical pharmacy · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of <euro>79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit-risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects.
Indexed as
Identifiers
24895178What 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.