SynthesisBasic & clinical pharmacology & toxicology2022
Biases in reporting of adverse effects in clinical trials, and potential impact on safety assessments in systematic reviews and therapy guidelines.
Synthesis in Basic & clinical pharmacology & toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Gastrointestinal issues predominate among side effects of medium-chain triglyceride consumption in humans.Frontiers in nutrition · 2026Pooled it
- A Systemic Review and Meta-analysis of the Incidence Rate of Interstitial Lung Disease in Patients with Unresectable Pancreatic Cancer Treated with Gemcitabine and Nab-paclitaxel Combination Therapy in the Japanese Population.Internal medicine (Tokyo, Japan) · 2025Pooled it
- Interleukin-receptor antagonist and tumour necrosis factor inhibitors for the primary and secondary prevention of atherosclerotic cardiovascular diseases.The Cochrane database of systematic reviews · 2024Pooled 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
- High-Frequency, At-Home Monitoring of Drug Safety and Tolerability in Clinical Trials: Results From Studies of Fluvoxamine for COVID-19 Treatment.Clinical and translational science · 2025Trial
- Safety Profile of Thread-Embedding Acupuncture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Biomedicines · 2026Review
- Future Clinical Pharmacological Decision Support.Basic & clinical pharmacology & toxicology · 2026Article
- Applications and Benefits of Dietary Supplements in Taekwondo: A Systematic Review.Life (Basel, Switzerland) · 2025Review
- Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications.BMC medical research methodology · 2025Observational
- Interpreting Safety Analyses in Psoriasis Clinical Trials.The Journal of clinical and aesthetic dermatologyReview
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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical trials are an important source of adverse effects data, including analyses in systematic reviews and recommendations in therapy guidelines. Trial publication bias may have profound effects on safety perceptions. This MiniReview presents and discusses biases in reporting of safety data in clinical trials and the implications for systematic reviews and guidelines.
objectivesThe objectives of this work are to analyse risk of gastrointestinal bleeding in systemic corticosteroid trials and to assess adverse effects reporting in a fluoxetine trial in depression (Treatment for Adolescents With Depression Study [TADS]) and descriptions of adverse effects in adolescent depression therapy guidelines.
methodsWe performed literature reviews and descriptive analyse of clinical trials with corticosteroids, and publications from the TADS trial. Risk of gastrointestinal bleeding from corticosteroids was analysed by meta-analysis.
findingsGastrointestinal bleeding definitions varied considerably between trials. The incidence was significantly increased in hospitalized, but not in ambulant, patients compared to placebo. We identified several biases concerning TADS safety reporting, including severity thresholds and nonpublication of most adverse effects data beyond the initial 12 weeks. Therapy guidelines on adolescent depression mentioned suicidality risk, but many failed to mention other adverse effects.
conclusionsWe identified several pitfalls in adverse effects reporting in clinical trials. These include heterogeneous disease definitions, reporting thresholds, and incomplete reporting. Trial bias may have great impact on risk assessments in systematic reviews and meta-analyses.
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.