ArticleClinical pharmacology and therapeutics2012
Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system.
Article in Clinical pharmacology and therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 46 citations in OpenAlex.
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- Article
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- Assessing the Benefits and Harms of Pharmacotherapy in Older Adults with Frailty: Insights from Pharmacoepidemiologic Studies of Routine Health Care Data.Drugs & aging · 2024Review
- High-Throughput Computing to Automate Population-Based Studies to Detect the 30-Day Risk of Adverse Outcomes After New Outpatient Medication Use in Older Adults with Chronic Kidney Disease: A Clinical Research Protocol.Canadian journal of kidney health and disease · 2024Article
- Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data.Drug safety · 2021Article
- Matching with time-dependent treatments: A review and look forward.Statistics in medicine · 2020Review
- The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.Endocrinology, diabetes & metabolism · 2020Article
- Cardiovascular safety of linagliptin compared with other oral glucose-lowering agents in patients with type 2 diabetes: A sequential monitoring programme in routine care.Diabetes, obesity & metabolism · 2019Article
- Using Real-World Data to Extrapolate Evidence From Randomized Controlled Trials.Clinical pharmacology and therapeutics · 2019Review
- Comparison group selection in the presence of rolling entry for health services research: Rolling entry matching.Health services research · 2019Article
- Development and application of two semi-automated tools for targeted medical product surveillance in a distributed data network.Current epidemiology reports · 2017Article
- Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin.Drug safety · 2017Article
- Transparency and Reproducibility of Observational Cohort Studies Using Large Healthcare Databases.Clinical pharmacology and therapeutics · 2016Article
- A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions.Drug safety · 2015Observational
- "First-wave" bias when conducting active safety monitoring of newly marketed medications with outcome-indexed self-controlled designs.American journal of epidemiology · 2014Article
- A modular, prospective, semi-automated drug safety monitoring system for use in a distributed data environment.Pharmacoepidemiology and drug safety · 2014Article
- Near-real-time monitoring of new drugs: an application comparing prasugrel versus clopidogrel.Drug safety · 2014Article
- Calendar time-specific propensity scores and comparative effectiveness research for stage III colon cancer chemotherapy.Pharmacoepidemiology and drug safety · 2013Article
- Pharmacovigilance using clinical notes.Clinical pharmacology and therapeutics · 2013Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
We developed a semi-automated active monitoring system that uses sequential matched-cohort analyses to assess drug safety across a distributed network of longitudinal electronic health-care data. In a retrospective analysis, we show that the system would have identified cerivastatin-induced rhabdomyolysis. In this study, we evaluated whether the system would generate alerts for three drug-outcome pairs: rosuvastatin and rhabdomyolysis (known null association), rosuvastatin and diabetes mellitus, and telithromycin and hepatotoxicity (two examples for which alerting would be questionable). Over >5 years of monitoring, rate differences (RDs) in comparisons of rosuvastatin with atorvastatin were -0.1 cases of rhabdomyolysis per 1,000 person-years (95% confidence interval (CI): -0.4, 0.1) and -2.2 diabetes cases per 1,000 person-years (95% CI: -6.0, 1.6). The RD for hepatotoxicity comparing telithromycin with azithromycin was 0.3 cases per 1,000 person-years (95% CI: -0.5, 1.0). In a setting in which false positivity is a major concern, the system did not generate alerts for the three drug-outcome pairs.
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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.