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

ABSTRACT:

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 ev

SUBMITTER: Boyne N 

PROVIDER: S-EPMC11800428 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature