Clinical trial registry documents and publication integrity.

Area of Science:

• Clinical trial research
• Publication ethics
• Regulatory science

Background:

• Ensuring the integrity of clinical trial publications is crucial for reliable medical research.
• Trial registration documents are intended to provide transparency and accountability in clinical research.

Purpose of the Study:

• To evaluate the integrity of clinical trial registration documents and their linked publications.
• To assess the impact of discrepancies and subsequent revisions on publication accuracy.

Main Methods:

• Evaluated 172 clinical trial publications and 138 unique trial registration documents.
• Identified and reported discrepancies in key trial characteristics between registrations and publications.
• Tracked revisions made to registration documents and assessed the timeliness and nature of these changes.

Main Results:

• 64% of trial registrations were retrospective.
• Discrepancies in ethics oversight, timelines, location, participant numbers, and sample size were found in 68 registration documents.
• Revisions to registrations were made a median of 44 months after initial registration, with a median of 8 changes per document, often altering primary outcomes and eligibility criteria.
• Despite reporting discrepancies and revisions, none of the affected publications were corrected by journals, publishers, or regulatory bodies eight months later.

Conclusions:

• Significant discrepancies exist between clinical trial registrations and publications, with many registrations being retrospective.
• Revisions to trial registrations are often delayed and substantial, impacting key study elements.
• Current regulatory and publishing frameworks may not adequately utilize trial registration documents to ensure publication integrity.