Reporting bias in completed epilepsy intervention trials: A cross-sectional analysis

Area of Science:

• Clinical Trials
• Neurology
• Biostatistics

Background:

• Reporting bias in clinical trials can skew evidence synthesis.
• Epilepsy intervention trials (EITs) are crucial for advancing neurological treatments.
• Compliance with regulatory requirements like the Food and Drug Administration Amendments Act (FDAAA) is essential for trial transparency.

Purpose of the Study:

• To assess the extent of reporting bias in completed epilepsy intervention trials.
• To evaluate the adherence of these trials to Food and Drug Administration Amendments Act (FDAAA) reporting timelines.
• To analyze trends in result reporting over time.

Main Methods:

• A systematic review of completed epilepsy intervention trials registered on ClinicalTrials.gov from 2008 to 2015.
• Descriptive data collection on trial characteristics and reporting status.
• Kaplan-Meier analysis to compare time to result reporting between different periods and assessment of FDAAA compliance.

Main Results:

• 25% of 126 completed epilepsy intervention trials did not report their results, indicating significant reporting bias.
• Trials completed between 2012-2015 had a significantly shorter time to result reporting (16.5 months) compared to those completed between 2008-2011 (25.9 months).
• Of trials conducted in the U.S. and meeting FDAAA criteria, only 34% reported results within the mandated one-year timeframe.

Conclusions:

• The substantial rate of non-reported epilepsy intervention trials highlights a critical reporting bias.
• Reporting bias in EITs should be a key consideration when assessing the risk of bias in epilepsy systematic reviews.
• Improved compliance with regulatory reporting mandates is necessary to enhance trial transparency and evidence reliability.