SynthesisWiener klinische Wochenschrift2021
Impact of literature reports on drug safety signals.
Synthesis in Wiener klinische Wochenschrift, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?Drug safety · 2025Article
- Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.Therapeutic advances in drug safety · 2023Review
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
backgroundSignal management is considered an important activity in pharmacovigilance and should be performed using any available source of data, including scientific literature. The main aim of this study was to assess the role of scientific literature in both indexed and unindexed journals and compare the relevance of both in the signal management process.
methodsThe study was a retrospective analysis of safety data. For the purposes of the study, drugs for which safety signals were evaluated by European Medicine Agency (EMA) were chosen. A match analysis of data collected in the EudraVigilance (EV) database with data from bibliographic databases such as MEDLINE, Embase or EBSCO (International Pharmaceutical Abstracts, IPA and the Allied and the Complementary Medicine Database, AMED) was performed.
resultsA total of 73 drug event associations (DEA) and 4160 individual case safety reports (ICSRs) were analyzed. About 33% of ICSRs were created based on scientific literature. A total of 1196 ICSRs were submitted to the EV database based on journals indexed in global bibliographic databases Embase (86.00%) or MEDLINE (81.96%) or EBSCO (IPA or AMED, 0.66%).
conclusionThis study underlines the importance of scientific literature for the signal management process in addition to other data sources. Most literature ICSRs from this analysis were created based on scientific journals indexed in bibliographic databases; therefore, it can be concluded that a systematic review of bibliographic databases, such as Embase or MEDLINE is highly relevant for the signal management process.
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.