Choice of randomisation time-point in non-inferiority studies of reduced treatment duration: experience from the SCOT study


Session type:

Jim Paul1, Jim Cassidy1, Rachel Midgley2, Tim Iveson3, Andrea Harkin1, Michelle Masterson2

1University of Glasgow, UK, 2University of Oxford, UK, 3Southampton University Hospitals NHS Trust, UK


In a non-inferiority study where the aim is to compare a reduced treatment duration there is a choice of two randomisation time-points. Patients can be randomised at the end of the reduced treatment period to continue or not, to the standard duration. This is optimum for maximising compliance, but has the disadvantage for the patient that treatment duration is not known from the outset.