ReviewTherapeutic innovation & regulatory science2023
Important Considerations for Signal Detection and Evaluation.
Review in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed, 5 citations in OpenAlex.
- Interstitial lung disease associated with antiandrogen agents: a pharmacovigilance study based on FDA adverse event reporting system.International urology and nephrology · 2026Article
- Enhancing Safety Evaluations: A Comprehensive Framework for Evidence-Based Safety Assessment Using the Bradford Hill Criteria.Therapeutic innovation & regulatory science · 2026Article
- Comparative risk of arrhythmias associated with systemic antifungal agents: a disproportionality analysis of the FAERS database.Frontiers in pharmacology · 2026Article
- Article
- Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials.Drug safety · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Safety clinicians have a wealth of resources describing how to perform signal detection. Nevertheless, there are some nuances concerning approaches taken by regulatory authorities and statistical considerations that should be appreciated. New approaches, such as the FDA Medical Queries, illustrate the value of considering medical concepts over individual adverse events. One area which would benefit from further clarity is how safety signals may be evaluated for evidence of a causal relationship to the drug of interest. Just as such safety signals can take many forms, the types of tools and methods required to interrogate these signals are equally as diverse. An understanding of the complexity of this process can aid the safety reviewer in successfully characterizing the emerging safety profile of a drug during the pre-marketing phase of development.
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.