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Introduction <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Discussion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月6日

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  • Nick Boyne,
  • Alison Duke,
  • Jack Rea,
  • Adam Khan,
  • Alec Young,
  • Jared Van Vleet,
  • Matt Vassar

摘要

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.