ArticleAmerican journal of public health2008
Adverse event detection in drug development: recommendations and obligations beyond phase 3.
Article in American journal of public health, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 6 of them syntheses 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
88 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Safety evaluation of Sodium-glucose cotransporter 2 inhibitors for cancer risk in specific populations: systematic review and meta-analysis.Frontiers in clinical diabetes and healthcare · 2026Pooled it
- Burden of corticosteroid therapy in patients with immunoglobulin A nephropathy (IgAN): a systematic literature review.BMC nephrology · 2025Pooled it
- Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials.Therapeutic innovation & regulatory science · 2024Pooled it
- Dietary supplements and herbal medicine for COVID-19: A systematic review of randomized control trials.Clinical nutrition ESPEN · 2021Pooled it
- Efficacy of Herbal Medicines Intervention for Colorectal Cancer Patients With Chemotherapy-Induced Gastrointestinal Toxicity - a Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- Model-based meta-analysis to evaluate optimal doses of direct oral factor Xa inhibitors in atrial fibrillation patients.Blood advances · 2018Pooled it
- Development of the Neuroimmune Modulator Ibudilast for the Treatment of Alcoholism: A Randomized, Placebo-Controlled, Human Laboratory Trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2017Trial
- Trial
- Uncovering hypothesis-generating associations between prescription drugs and digestive cancer risk: a case-control drug-wide association study (DWAS).Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026Article
- Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars.Journal of managed care & specialty pharmacy · 2026Article
- Efficacy and safety of mazdutide vs. dulaglutide in adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.Diabetology & metabolic syndrome · 2026Article
- Knowledge, attitudes and practices of health care professionals towards pharmacovigilance in Georgia.BMC health services research · 2026Article
- Informative relational learning for adverse reaction prediction with enhanced generalization to novel drugs.Bioinformatics (Oxford, England) · 2026Article
- Toxicological evaluation of Lagerstroemia speciosa (L.) Martyn and Lagerstroemia tomentosa C.Presl extracts using a liver organ-on-a-chip system.Scientific reports · 2026Article
- Review
- Social media data and its potential for pharmacovigilance: a comparative analysis of reported prevalences regarding drug-induced gingival overgrowth (DIGO).Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- Explainable drug side effect prediction in central neural system via biologically informed graph neural network.Translational psychiatry · 2026Article
- Cross national pharmacovigilance analysis of drug-induced delirium: a comparative study using the US FAERS, Japanese JADER, and canadian CVAR datasets.Frontiers in pharmacology · 2026Article
- Sustained-Release Intra-Articular Drug Delivery: PLGA Systems in Clinical Context and Evolving Strategies.Pharmaceutics · 2025Review
28 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
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record databases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing surveillance is essential for developing a full understanding of the balance between benefits and adverse effects. More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies.
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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.