ArticleTrials2019
Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 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
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis.Rheumatology international · 2024Pooled it
- Risk of Adverse Events Associated with Domperidone and Metoclopramide in Gastroparesis: Systematic Review and Meta-analysis.Drugs in R&D · 2023Pooled 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
- Individual participant data meta-analysis versus aggregate data meta-analysis: A case study in eczema and food allergy prevention.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2022Pooled it
- The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial.PM & R : the journal of injury, function, and rehabilitation · 2022Trial
- Trial
- Article
- Do we value the safety of our treatments? An empirical assessment of reporting of Harms in Randomized Controlled Trials in Orthodontics.European journal of orthodontics · 2025Article
- Mitapivat-Associated Adverse Effects and Potential Mechanistic: Insights From Real-World Data.Journal of cellular and molecular medicine · 2025Article
- Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications.BMC medical research methodology · 2025Observational
- Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events.Drugs - real world outcomes · 2024Article
- Recommendations on recording harms in randomised controlled trials of behaviour change interventions.BMJ (Clinical research ed.) · 2024Article
- Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses.Systematic reviews · 2023Article
- Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials.Epidemiologic reviews · 2022Article
- Harms in Systematic Reviews Paper 1: An introduction to research on harms.Journal of clinical epidemiology · 2022Article
- Harms in Systematic Reviews Paper 3: Given the same data sources, systematic reviews of gabapentin have different results for harms.Journal of clinical epidemiology · 2022Article
- Harms in Systematic Reviews Paper 2: Methods used to assess harms are neglected in systematic reviews of gabapentin.Journal of clinical epidemiology · 2022Article
- Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation.BMJ open · 2021Article
- Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications-a methodological review.BMC medicine · 2021Article
- Efficacy and safety outcomes of proposed randomized controlled trials investigating hydroxychloroquine and chloroquine during the early stages of the COVID-19 pandemic.British journal of clinical pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundAdverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions.
methodsWe compared the methods authors use to decide which AEs to include in a particular source (i.e., "selection criteria"), including the number of different types of AEs reported (i.e., rather than the number of events). We compared sources (e.g., journal articles, clinical study reports (CSRs)) of trials for two drug-indications-gabapentin for neuropathic pain and quetiapine for bipolar depression. Electronic searches were completed in 2015. We identified selection criteria and assessed how criteria affected AE reporting.
resultsWe identified 21 gabapentin and 7 quetiapine trials. We found 6 gabapentin CSRs and 2 quetiapine CSRs, all written by drug manufacturers. All CSRs reported all AEs without applying selection criteria; by comparison, no other source reported all AEs, and 15/68 (22%) gabapentin sources and 19/48 (40%) quetiapine sources reported using selection criteria. Selection criteria greatly affected the number of AEs reported. For example, 67/316 (21%) AEs in one quetiapine trial met the criterion "occurring in ≥2% of participants in any treatment group," while only 5/316 (2%) AEs met the criterion "occurring in ≥10% of quetiapine-treated patients and twice as frequent in the quetiapine group as the placebo group."
conclusionsSelection criteria for reporting AEs vary across trials and across sources for individual trials. If investigators do not pre-specify selection criteria, they might "cherry-pick" AEs based on results. Even if investigators pre-specify selection criteria, selective reporting will produce biased meta-analyses and clinical practice guidelines. Data about all AEs identified in clinical trials should be publicly available; however, sharing data will not solve all the problems identified in this study.
Indexed as
Identifiers
What Socratic 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 Socratic graph.