Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

Area of Science:

• Pediatric clinical research
• Drug safety surveillance
• Evidence-based medicine

Background:

• Randomized controlled trials (RCTs) are crucial for understanding adverse drug reactions (ADRs).
• The Consort group developed recommendations to enhance the quality of ADR reporting in clinical trials.
• The application of these recommendations in pediatric RCTs has not been thoroughly evaluated.

Purpose of the Study:

• To assess the adherence to Consort reporting recommendations in pediatric randomized controlled trials.
• To identify deficiencies in the reporting of adverse drug reactions in pediatric research.
• To evaluate factors influencing the quality of safety data reporting in pediatric RCTs.

Main Methods:

• A literature search was conducted to identify relevant pediatric RCTs.
• The identified articles were analyzed for their reporting of adverse drug reactions and adherence to Consort guidelines.
• Data on standardized methods, tabulation of reactions, and withdrawal reasons were extracted.

Main Results:

• Out of 107 pediatric RCTs reviewed, 78% mentioned adverse drug reactions.
• Only 34% used standardized methods for disclosure, and 31% tabulated reactions.
• Adequate reporting of safety data, according to Consort guidelines, was found in only 18% of the studies.
• Industry sponsorship was associated with better reporting, while RCT registration did not influence reporting.

Conclusions:

• Adverse drug reaction reporting in pediatric RCTs is frequently inadequate.
• Authors should proactively define and monitor adverse events, reporting them according to extended Consort recommendations.
• Both authors and editors share responsibility for improving the reporting of safety data in pediatric clinical trials.