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

Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288 (Electronic) Linking ISSN: 14712288 NLM ISO Abbreviation: BMC Med Res Methodol Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Chronic Pain*/therapy; Humans ; Retrospective Studies ; Randomized Controlled Trials as Topic/standards ; Randomized Controlled Trials as Topic/statistics & numerical data ; Back Pain/therapy ; Registries/statistics & numerical data ; Patient Safety/standards ; Patient Safety/statistics & numerical data ; Publications/statistics & numerical data ; Publications/standards

Introduction: Chronic back pain (CBP) is a leading cause of disability worldwide and is commonly managed with pharmacological, non-pharmacological, and procedural interventions. However, adverse event (AE) reporting for these therapies often lacks transparency, raising concerns about the accuracy of safety data. This study aimed to quantify inconsistencies in AE reporting between ClinicalTrials.gov and corresponding randomized controlled trial (RCT) publications, emphasizing the importance of comprehensive safety reporting to improve clinical decision-making and patient care.
Methods: We retrospectively analyzed Phase 2-4 CBP RCTs registered on ClinicalTrials.gov from 2009 to 2023. Extracted data included AE reporting, trial sponsorship, and discrepancies in serious adverse events (SAEs), other adverse events (OAEs), mortality, and treatment-related withdrawals between registry entries and publications. Statistical analyses assessed reporting inconsistencies, following STROBE guidelines.
Results: A total of 114 registered trials were identified, with 40 (35.1%) corresponding publications. Among these, 67.5% were industry-sponsored. Only 4 (10%) publications fully reported adverse events (AEs) without discrepancies, while 36 (90%) contained at least one inconsistency compared to ClinicalTrials.gov. Discontinuation due to AEs was explicitly reported in 24 (60%) of ClinicalTrials.gov entries and in 30 (75%) of publications, with discrepancies in 16 trials (40%). Serious adverse events (SAEs) were reported differently in 15 (37.5%) publications; 80% reported fewer SAEs than ClinicalTrials.gov. Other adverse events (OAEs) showed discrepancies in 37 (92.5%) publications, with 43.2% reporting fewer and 54.1% reporting more OAEs.
Discussion: 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.
Competing Interests: Declarations. Ethics approval and consent to participate: The Oklahoma State University Center for Health Sciences Institutional Review Board reviewed the study protocol and determined that the research qualifies as nonhuman subjects research, in accordance with 45 CFR 46.102(d) and (f). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
(© 2025. The Author(s).)

PLoS Med. 2016 Sep 20;13(9):e1002127. (PMID: 27649528)
BMC Med Res Methodol. 2022 Oct 5;22(1):262. (PMID: 36199040)
BMJ. 2014 Nov 21;349:g6501. (PMID: 25416499)
Adv Ther. 2023 May;40(5):2082-2096. (PMID: 36947330)
J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. (PMID: 33616650)
Fed Regist. 2016 Sep 21;81(183):64981-5157. (PMID: 27658315)
Ann Intern Med. 2017 Apr 4;166(7):514-530. (PMID: 28192789)
Ann Intern Med. 2007 Oct 2;147(7):478-91. (PMID: 17909209)
Can Fam Physician. 2018 Nov;64(11):832-840. (PMID: 30429181)
JAMA Dermatol. 2015 Jun;151(6):600-6. (PMID: 25830296)
J Clin Oncol. 2013 Nov 1;31(31):3957-63. (PMID: 24062406)
Trials. 2019 Sep 5;20(1):553. (PMID: 31488200)
Biomed Inform Insights. 2017 Jun 08;9:1178222617713018. (PMID: 28634427)
Spine (Phila Pa 1976). 2020 Aug 15;45(16):1135-1142. (PMID: 32097269)
Lancet Rheumatol. 2023 May 22;5(6):e316-e329. (PMID: 37273833)
Basic Clin Pharmacol Toxicol. 2022 Dec;131(6):465-473. (PMID: 36125975)
PLoS Med. 2013 Oct;10(10):e1001526. (PMID: 24115912)
Rheumatol Int. 2019 Apr;39(4):619-626. (PMID: 30848349)
J Pain. 2016 Nov;17(11):1137-1149. (PMID: 27522950)
Phlebology. 2024 Mar;39(2):80-95. (PMID: 37902099)
Syst Rev. 2016 Jul 08;5(1):108. (PMID: 27392044)
Am J Gastroenterol. 2009 Mar;104(3):728-38. (PMID: 19240698)
PLoS One. 2015 May 21;10(5):e0127495. (PMID: 25996928)
J Clin Oncol. 2014 Jan 10;32(2):83-9. (PMID: 24323037)
BMC Med. 2020 May 29;18(1):137. (PMID: 32466758)
BMJ. 2023 Apr 24;381:e073725. (PMID: 37094878)
Ann Intern Med. 2014 Apr 1;160(7):477-83. (PMID: 24687070)

Keywords: Adverse events; Chronic back pain; ClinicalTrials.gov; Randomized controlled trials; Safety reporting

Date Created: 20250206 Date Completed: 20250206 Latest Revision: 20250210

20250210

PMC11800428

10.1186/s12874-025-02486-5

39915715