ArticleDrug safety2018
Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 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
- Signals of Venous Thromboembolism Risk from Drug-Drug Interactions Involving Benzodiazepines and Other Sedative Hypnotics: Self-Controlled Case Series Analyses.Clinical drug investigation · 2026Article
- Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD).Pharmacoepidemiology and drug safety · 2025Article
- Article
- Grace periods and exposure misclassification in self-controlled case-series studies of drug-drug interactions.American journal of epidemiology · 2025Article
- Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies.Drug safety · 2024Review
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- Machine Learning in Causal Inference: Application in Pharmacovigilance.Drug safety · 2022Review
- Finding Potential Adverse Events in the Unstructured Text of Electronic Health Care Records: Development of the Shakespeare Method.JMIRx med · 2021Article
- The emerging landscape of health research based on biobanks linked to electronic health records: Existing resources, statistical challenges, and potential opportunities.Statistics in medicine · 2020Article
- Hypothesis-free signal detection in healthcare databases: finding its value for pharmacovigilance.Therapeutic advances in drug safety · 2019Article
- First Conference on Big Data for Pharmacovigilance.Drug safety · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
introductionThe Self-Controlled Case Series (SCCS) method has been widely used for hypothesis testing, but there is limited evidence of its performance for safety signal detection.
objectiveThe objective of this study was to evaluate SCCS for signal detection on recently approved products.
methodsA retrospective study covered the period after three recently marketed drugs were launched through to 31 December 2010 using The Health Improvement Network, a UK primary care database, and Optum, a US claims database. The SCCS method was applied to examine five heterogenous outcomes with desvenlafaxine and escitalopram and six outcomes with adalimumab for Signals of Disproportional Recording (SDRs); a positive finding was determined to be when the lower bound of 95% Confidence Interval of the incidence rate ratio (IRR) estimate was > 1. Multiple design choices were tested and the trend in IRR estimates over calendar time for one drug event pair was examined.
resultsAll six outcomes with adalimumab, three of five outcomes with desvenlafaxine, and four of five outcomes with escitalopram had SDRs. SCCS highlighted all acute events in the primary analysis but was less successful with slower-onset outcomes. Performance varied by risk period definition. Changes in IRR estimates over quarterly intervals for adalimumab with herpes zoster showed marked higher SDR within 9 months of drug launch.
conclusionSCCS shows promise for signal detection: it may highlight known associations for recent marketed products and has potential for early signal identification. SCCS performance varied by design choice and the nature of both exposure and event pair. Future work is needed to determine how effective the approach is in prospective testing and determining the performance characteristics of the approach.
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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.