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Background So far, NI trials are almost exclusively performed in phase III setting. However, the NI question might already be relevant in phase II setting in several scenarios, like: treatment optimization in diseases for which standard treatments already exist, or investigation of cytostatic agents, or rare diseases for which a phase III trial will not be feasible, or try to establish a reduced dose for frail patients. Before pursuing a phase III NI trial, a phase II trial is warranted. If resources are limited, then the scale of the phase II trials might be constrained. Feasible design choices for small-scale phase II trial with NI intention are desired.

Design choices for small-scale phase II trials with non-inferiority (NI) intention