Optimal adaptive two-stage designs for early phase II clinical trials.

Abstract

Simon's optimal two-stage design has been widely used in early phase clinical trials for Oncology and AIDS studies with binary endpoints. With this approach, the second-stage sample size is fixed when the trial passes the first stage with sufficient activity. Adaptive designs, such as those due to Banerjee and Tsiatis (2006) and Englert and Kieser (2013… (More)
DOI: 10.1002/sim.6794

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