ReviewClinical pharmacology and therapeutics2021
A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring.
Review in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 1 of them a synthesis that pooled it.
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
72 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Barriers in reporting adverse effects of medical devices: a literature review.Naunyn-Schmiedeberg's archives of pharmacology · 2025Pooled it
- Leveraging Administrative Health Data to Capture Rare Adverse Drug Reactions: Identifying Pediatric Patients With Trimethoprim-Sulfamethoxazole Acute Respiratory Distress Syndrome.Pharmacology research & perspectives · 2026Article
- Hepatic Safety Profile of Atomoxetine and Methylphenidate in Patients with ADHD: Disproportionality Analysis Using EudraVigilance Database Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Informative relational learning for adverse reaction prediction with enhanced generalization to novel drugs.Bioinformatics (Oxford, England) · 2026Article
- Influence of drugs on blood potassium levels in older, multi-medicated patients - results of two cohort studies focusing on adverse drug reactions.BMC geriatrics · 2026Article
- Review
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Article
- Trends in adverse drug reaction reporting by dentists: a 15-year analysis of German pharmacovigilance data.Clinical oral investigations · 2026Article
- Respiratory drugs and psychiatric adverse events in children and adolescents: a pharmacovigilance study based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Post-marketing safety signals of Wilson's disease therapies: evidence from FAERS and VigiBase.Orphanet journal of rare diseases · 2026Article
- Enhancing evidence-based care using trial emulation in electronic health records: real-world effects of empagliflozin in people with type 2 diabetes.BMJ open diabetes research & care · 2026Article
- Performance of the Self-Controlled Case Series for Drug Safety Signal Detection: A Multi-Database Study.Pharmacoepidemiology and drug safety · 2026Article
- Risk assessment of drug-associated miscarriage using XGBoost and SHAP explainability: a real-world pharmacovigilance analysis based on the FAERS database.Frontiers in pharmacology · 2026Article
- Pharmacoepidemiology unpacked: a roadmap for junior researchers.Frontiers in pharmacology · 2026Review
- Safety of individualized herbal medicine for dysmenorrhea: pharmacovigilance from South Korea's national pilot.Frontiers in pharmacology · 2026Article
- Disparities and trends in drug-related adverse reaction mortality in the United States, 1999-2020.Therapeutic advances in drug safety · 2026Article
- Ranking the Diabetes-related Safety Profile of Different Statin Drugs.Current pharmaceutical design · 2026Article
- Real-World Data on Severe Cutaneous Adverse Reactions to Drugs.Pharmaceuticals (Basel, Switzerland) · 2025Article
- FLT1 as a Protective Factor in Ischemic Stroke: Insights from Real-World Pharmacovigilance and Genetic Evidence.Translational stroke research · 2025Article
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory phase IV clinical trials, black box warnings, and withdrawal of drugs from the market. Real-world data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices. Some of these platforms are well-established while others are still emerging or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring. Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.
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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.