Completeness of protocols for clinical trials in children submitted to ethics committees.
Pathma D JosephPatrina H Y CaldwellElizabeth H BarnesKay HynesCatherine S ChoongSean TurnerClaire VoskJessie WhiteKate RichichiJonathan C CraigPublished in: Journal of paediatrics and child health (2018)
Protocols of trials involving children assessed by ethics committees generally include details on background and basic design, but many key domains in trial design and conduct are not covered. Despite widespread recognition of how problems in the design and conduct of trials may lead to unreliable results, investigators still appear to be omitting key elements in trial protocols.