Journal article

Reporting of data monitoring committees and adverse events in paediatric trials: A descriptive analysis

A Gates, P Caldwell, S Curtis, L Dans, RM Fernandes, L Hartling, LE Kelly, B Vandermeer, K Williams, K Woolfall, MP Dyson

BMJ Paediatrics Open | Published : 2019

Abstract

ObjectivesFor 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints.MethodsFor this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics.ResultsEighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a..

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