ReviewTrials2012
Drug safety assessment in clinical trials: methodological challenges and opportunities.
Review in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 7 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
97 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Biases in reporting of adverse effects in clinical trials, and potential impact on safety assessments in systematic reviews and therapy guidelines.Basic & clinical pharmacology & toxicology · 2022Pooled it
- Bayesian sparse modeling to identify high-risk subgroups in meta-analysis of safety data.Research synthesis methods · 2022Pooled it
- Systematic review and meta-analysis of head-to-head trials comparing sulfonylureas and low hypoglycaemic risk antidiabetic drugs.BMC endocrine disorders · 2022 · on this mapPooled it
- Inhaled corticosteroids and risk of influenza in patients with asthma: a meta-analysis of randomized controlled trials.Aging clinical and experimental research · 2021Pooled it
- Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials.Malaria journal · 2020Pooled it
- Pooled it
- Quality of reporting in systematic reviews of adverse events: systematic review.BMJ (Clinical research ed.) · 2014Pooled it
- Inferences About Drug Safety in Phase III Trials in Oncology: Examples From Advanced Prostate Cancer.Journal of the National Cancer Institute · 2021Trial
- The evaluation of thioridazine as a hematopoietic progenitor cell mobilizing agent in healthy human subjects.Journal of clinical pharmacology · 2015Trial
- Assessment of United States Food and Drug Administration Approval of Cell and Gene Therapies.Clinical pharmacology and therapeutics · 2026Article
- Repurposing of colchicine: critical examination of clinical trials and scoping review.European journal of clinical pharmacology · 2026Article
- Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium-glucose cotransporter 2 inhibitor users.British journal of clinical pharmacology · 2026Article
- Comment on 'A Prospective Evaluation of Glucagon Stimulation Test Safety in Adults With Chronic Moderate-to-Severe Traumatic Brain Injury'.Endocrinology, diabetes & metabolism · 2026Article
- A Generative AI Framework for Pharmacokinetic Clinical Study Report Authoring.Clinical and translational science · 2026Article
- Moving Mendelian Randomization From Traditional Risk Factors to Molecular Targets for Drug Development and Clinical Trials in Nephrology.Kidney international reports · 2026Review
- Risk of depression with GLP-1 receptor agonists use in overweight or obese adults with type 2 diabetes: A new-user, active-comparator cohort study.Diabetes, obesity & metabolism · 2026Article
- Disproportionality analysis of off-label intravitreal bevacizumab in the FDA Adverse Event Reporting System database.Therapeutic advances in drug safety · 2026Article
- Immuno-OncologyThe adverse event of interstitial lung disease in patients treated with antibody-drug conjugates.The oncologist · 2025Article
- Review
- Review
37 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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patients. We summarize the principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials using recent examples from systematic reviews. These challenges include the lack of an evidentiary gold standard, the limited statistical power of randomized controlled trials and resulting type 2 error, the lack of adequate ascertainment of adverse events and limited generalizability of trials that exclude high risk patients. We discuss potential solutions to these challenges. Evaluation of drug safety requires careful examination of data from heterogeneous sources. Meta-analyses of drug safety should include appropriate statistical methods and assess the optimal information size to avoid type 2 errors. They should evaluate outcome reporting biases and missing data to ensure reliable and accurate interpretation of findings. Regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.