ABSTRACT
Often, phase II protocols have multiple experimental therapies for efficacy screening with respect to the same patient population. Usually, the resources for clinical trials are limited, so that we may want to choose only a small number of therapies, ideally one therapy, to be compared with a standard therapy through a phase III trial. In this setting, we may take one of two approaches: (i) conduct multiple separate phase II trials, one for each experimental therapy, and evaluate them independently using a standard phase II trial design method for a single-arm phase II trial; (ii) conduct a single phase II trial with multiple experimental arms, randomize patients into the arms, and choose the best arm(s) using a selection method. The former approach requires more research resources due to the multiplicity of the studies. Also, the individual phase II trials may potentially have different patient characteristics, and the comparison among different therapies can be biased.
