Trial participants are at a different position in treatment pathway

‘Treatment pathway’ refers to the sequence of previous treatments received, based on patient selection criteria and response to previous therapies, often reflected in clinical guidelines. The position of patients in the treatment pathway drives the choice of appropriate comparator.

The position in the treatment pathway occupied by trial participants may differ from that which they would occupy in usual practice in the healthcare system of interest. For example, in usual practice the new medicine may be considered for use (only) after the disease progressed on two types of therapy, whereas trial participants may have experienced disease progression on just one. This assumes that the pathway has not changed during the course of the trial.