ArticleDrug safety2025
Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance.
Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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.
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Who cites it
18 citing papers in PubMed.
- From Product-Quality Complaints to Patient-Safety Triage: A Structured Narrative Review and Proposed PRCS-TRACE Framework.Healthcare (Basel, Switzerland) · 2026Review
- Real-World Patterns of Delayed Cutaneous Adverse Reactions to Antimicrobial Therapy in Children: A Case Series and FAERS Analysis Across Age Groups.Antibiotics (Basel, Switzerland) · 2026Article
- Comparative Risk of Hyponatremia Among Patients Treated With Second-Generation Antipsychotics.JAMA network open · 2026Article
- Digoxin Dosing Errors, Drug Interactions and Off-Label Risks: Insights from an EudraVigilance Disproportionality Analysis.Journal of clinical medicine · 2026Article
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- Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group.Drug safety · 2026Article
- Post-marketing safety signals of Wilson's disease therapies: evidence from FAERS and VigiBase.Orphanet journal of rare diseases · 2026Article
- Pharmacovigilance Through Fresh Eyes: The International Society of Pharmacovigilance Student Community's Role in Shaping the Future of Pharmacovigilance.Drug safety · 2026Article
- Real-world evidence in metabolic dysfunction-associated steatotic liver disease (MASLD): insights, challenges, and future directions.The Lancet regional health. Europe · 2026Review
- Artificial Intelligence for Drug Safety Across the Lifecycle and Decision Type: A Scoping Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Global patterns and trends in spontaneous reporting systems: VigiBase, FAERS, VAERS, and JADER.Frontiers in drug safety and regulation · 2026Article
- Sequential analysis for post-marketing drug safety surveillance using routinely collected electronic healthcare data: a scoping review.Therapeutic advances in drug safety · 2026Article
- How is AI developing in pharmacovigilance?Therapeutic advances in drug safety · 2026Article
- Global burden of TNF-α inhibitors associated demyelinating diseases: A global disproportionality analysis.Medicine · 2025Observational
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- CRISPR and Artificial Intelligence in Neuroregeneration: Closed-Loop Strategies for Precision Medicine, Spinal Cord Repair, and Adaptive Neuro-Oncology.International journal of molecular sciences · 2025Review
- Development and validation of a predictive nomogram for severe adverse drug reactions: a dual-center pharmacovigilance study.Frontiers in pharmacology · 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
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Signal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging data from spontaneous reporting databases (SRDs), which represent the cornerstone of pharmacovigilance. However, the exponentially increasing generation and availability of real-world data collected in longitudinal healthcare databases (LHDs), along with the rapid evolution of artificial intelligence-based algorithms and other advanced analytical methods, offers a wide range of opportunities to complement SRDs throughout all stages of signal management, especially signal detection. Integrating information derived from SRDs and LHDs may reduce their respective limitations, thus potentially enhancing post-marketing surveillance. The aim of this position statement is to critically evaluate the complementary role of SRDs and LHDs in signal management, exploring the potential benefits and challenges in integrating information coming from these two data sources. Furthermore, we presented successful cases of the interplay between SRDs and LHDs for signal management, along with future opportunities and directions to improve such interplay.
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What Socratic 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 Socratic graph.