Discrepancies in Safety Reporting for Chronic Back Pain Clinical Trials: An Observational Study from ClinicalTrials.gov and Publications

    February 2025 in “ BMC Medical Research Methodology
    Nicholas Boyne, Alison Duke, J N Rea, Adam Khan, Alec Young, Jared Van Vleet, Matt Vassar
    TLDR Inconsistent safety reporting in chronic back pain trials risks patient safety and decision-making.
    The study identifies significant discrepancies in adverse event (AE) reporting for chronic back pain (CBP) clinical trials, which compromise the reliability of published safety data and pose risks to clinical decision-making and patient safety. It suggests that adopting standardized reporting guidelines like CONSORT Harms and ensuring transparent updates in publications could improve the accuracy and trustworthiness of safety data. The study calls for journals and regulatory bodies to enforce compliance and recommends developing mechanisms to monitor and correct reporting inconsistencies to enhance the trustworthiness of safety data in clinical research.
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