Design Issues in Randomized Phase II/III Trials

摘要: Phase II trials are used to show sufficient preliminary activity of a new treatment (in single-arm designs or randomized screening designs) select among treatments with demonstrated selection designs). The prioritized in phase trial then tested definitively against control III trial. Randomized II/III use an adaptive design that combines these two types one, potential gains time and reduced numbers patients required be treated. Two key considerations designing whether suspend accrual while the data mature choice target effect. We discuss parameters, give examples trials, provide recommendations concerning efficient designs.