Internal pilot and stopping rules
GHD reversers, GHD
RECRUITMENT, GHD
To ensure the success of the trial, screening data will be kept on the GHD Reversal Trial database on the number of early re-tests, GHD reversers and recruits. No patient identifiable information will be collected at this stage. These data will be analysed and presented as part of the progress report for the trial steering committee (TSC). According to published standards, Amber and Red ‘Stop/Go’ criteria have been agreed with the Funder. Time points are calculated from first centre opening. Three Stop–Go criteria measurable in the first 12 months of the trial were identified as critical steps for the trial’s successful recruitment (see Table GHD Reversal Trial Stop/Go criteria