Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications

This study highlights pervasive discrepancies in AE reporting for CBP trials, undermining the reliability of published safety data. Inconsistent reporting poses risks to clinical decision-making and patient safety. Adopting standardized reporting guidelines, such as CONSORT Harms, and ensuring transparent updates in publications could enhance the accuracy and trustworthiness of safety data. Journals and regulatory bodies should enforce compliance and future efforts should develop mechanisms to monitor and correct reporting inconsistencies, enhancing the trustworthiness of safety data in clinical research.

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Publication Details

Journal
BMC Medical Research Methodology
Published
2025-02-06
DOI
https://doi.org/10.1186/s12874-025-02486-5
Citations
6
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
18.79
Controls
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article

Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications

Nicholas Boyne, Matt Vassar, Adam Khan, J N Rea et al.
6 citations
BMC Medical Research Methodology
Health Systems, Economic Evaluations, Quality of Life
18.79
article

Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications

Nicholas Boyne, Matt Vassar, Adam Khan, J N Rea, Alec Young, Alison Duke, Jared Van Vleet
article en
6 citations

Abstract

This study highlights pervasive discrepancies in AE reporting for CBP trials, undermining the reliability of published safety data. Inconsistent reporting poses risks to clinical decision-making and patient safety. Adopting standardized reporting guidelines, such as CONSORT Harms, and ensuring transparent updates in publications could enhance the accuracy and trustworthiness of safety data. Journals and regulatory bodies should enforce compliance and future efforts should develop mechanisms to monitor and correct reporting inconsistencies, enhancing the trustworthiness of safety data in clinical research.

BMC Medical Research MethodologyVol. 25(1)
Oklahoma State University Center for Health Sciences (US)
Openalex Percentile: Top 1%
Health Systems, Economic Evaluations, Quality of Life
18.79
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