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

Allison GatesPatrina CaldwellSarah CurtisLeonila DansRicardo M FernandesLisa HartlingLauren E KellyBen VandermeerKatrina WilliamsKerry WoolfallMichele P Dyson

Published in: BMJ paediatrics open (2019)

The reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.

Keyphrases

adverse drug
electronic health record
emergency department
intensive care unit
drug induced
big data