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