ArticleBMJ open2014
Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.
Article in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 8 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
28 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Comparative efficacy of antidepressants for acute adolescent major depressive disorder: a source-verified systematic review and network meta-analysis.Frontiers in psychiatry · 2026Pooled it
- Systematic review with cross sectional comparative analysis identifies adverse event reporting discrepancies between ClinicalTrials.gov and published glaucoma randomized controlled trials.Scientific reports · 2025Pooled 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
- Association of antipsychotic use with breast cancer: a systematic review and meta-analysis of observational studies with over 2 million individuals.Epidemiology and psychiatric sciences · 2022Pooled it
- Benefits and harms of the human papillomavirus (HPV) vaccines: comparison of trial data from clinical study reports with corresponding trial register entries and journal publications.Systematic reviews · 2020Pooled it
- Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017Pooled it
- Precursors to suicidality and violence on antidepressants: systematic review of trials in adult healthy volunteers.Journal of the Royal Society of Medicine · 2016Pooled it
- Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.PLoS medicine · 2016Pooled it
- Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.BMJ (Clinical research ed.) · 2015Trial
- Article
- Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.Pharmaceutical medicine · 2026Review
- The effect and safety of sleep interventions on suicidal thoughts and behavior - A systematic review and meta-analyses.Sleep medicine: X · 2025Review
- Comparative cardiometabolic safety and effectiveness of aripiprazole in people with severe mental illness: A target trial emulation.PLoS medicine · 2025Observational
- Reply: Fetal safety of dydrogesterone: clarifying the role of pharmacovigilance.Human reproduction open · 2025Article
- Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review.BMJ medicine · 2023Article
- Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study.BMC medical research methodology · 2022Observational
- Duloxetine versus 'active' placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.Systematic reviews · 2021Article
- A Holistic Self-learning Approach for Young Adult Depression and Anxiety Compared to Medication-Based Treatment-As-Usual.Community mental health journal · 2021Article
- Stem cells part of the innate and adaptive immune systems as a therapeutic for Covid-19.Communicative & integrative biology · 2021Review
- Obstacles to the reuse of study metadata in ClinicalTrials.gov.Scientific data · 2020Article
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
objectiveTo examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies.
designCross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles.
settingClinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health.
main outcome measure3 coders extracted data on the numbers and types of SAEs.
results244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles' (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; p<0.001) times more likely to be published with no discrepancy in their associated journal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov.
conclusionsSubstantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a pressing concern.
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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.