Assessing the completeness of safety reporting in clinical trials of regional anesthesia interventions: a registry-publication comparison systematic review.

In 30 seconds

This systematic review evaluated the completeness of adverse event (AE) reporting in interventional regional anesthesia trials registered on ClinicalTrials.gov and their corresponding publications. The study found significant discrepancies in AE counts, with trials under FDA reporting requirements showing improved completeness. Notably, industry-sponsored trials had higher AE reporting scores.

Key findings

• Substantial discrepancies in AE counts were found between ClinicalTrials.gov and publications.
• Trials under FDA reporting requirements were significantly more likely to report complete AE data (p<0.05).
• Industry-sponsored and drug-focused trials had higher composite AE reporting scores.
• A modest increase in reporting completeness was observed post-Final Rule, though recent instability limits interpretation.

Why it matters

Incomplete reporting of adverse events can obscure the safety profiles of interventions, potentially impacting clinical decision-making and patient safety. Standardized reporting practices are essential for accurate risk communication in anesthesiology.