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.
Authors
- Nicholas Boyne
- Matt Vassar
- Adam Khan (ORCID: https://orcid.org/0000-0003-1358-5119)
- J N Rea (ORCID: https://orcid.org/0000-0002-1323-0847)
- Alec Young
- Alison Duke (ORCID: https://orcid.org/0009-0001-0307-9928)
- Jared Van Vleet
Institutions
- Oklahoma State University Center for Health Sciences (US)
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