Cross-sectional analysis of safety reporting in sleep disorder clinical trials.

Authors

Makalie Lackey, Caden Forbes, Kellen Keefer, Rachel Hazlitt, Tag Harris, Daniel Archer, Logan Corwin, Alicia Ito Ford, Matt Vassar

Published in

BMJ open. Volume 16. Issue 9. Pages e112962. Sep 08, 2026. Epub Sep 08, 2026.

Abstract

Adverse event reporting is critical for evaluating the safety of interventions in sleep disorders. Inconsistent reporting between trial registries and publications may alter clinical decision-making and patient safety. We assessed the concordance of adverse event reporting between ClinicalTrials.gov and peer-reviewed publications for interventional trials in sleep disorders. Primary outcomes included the consistency of reporting serious adverse events, other adverse events and patient/event counts. The location and detail of adverse event reporting within publications were also evaluated.
RESULTS: Among 168 trials, 143 (85.1%) showed discrepancies in serious adverse event counts between registry and publication. Patient count variations occurred in 73.2% and 35.1% of publications reported no adverse event data. Post-Final Rule trials demonstrated improved registry-based reporting, though discordance remained.
Substantial inconsistencies in adverse event reporting between registries and publications persist in sleep disorder trials. Improved standardisation and adherence to reporting guidelines are necessary to protect patient safety.
Registered on Open Science Framework.

PMID:
42711075
Bibliographic data and abstract were imported from PubMed on 09 Sep 2026.

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