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Phase II studies in oncology are frequently conducted as two‐stage single‐arm trials with a binary endpoint indicating tumor response. As a common feature of these designs, the sample sizes of the two stages and the decision rules for the interim and the final analysis have to be pre‐specified and adhered to strictly during the course of the trial in order to assure control of the type I error rate...
Summary Phase II trials in oncology are usually conducted as single‐arm two‐stage designs with binary endpoints. Currently available adaptive design methods are tailored to comparative studies with continuous test statistics. Direct transfer of these methods to discrete test statistics results in conservative procedures and, therefore, in a loss in power. We propose a method based on the conditional...
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