Article

BUDS: Benchmark Uncertainty Design Selection for Two-Stage Single-Arm Phase II Trials

2026-05-18

Abstract excerpt

<h4>Background</h4> Simon two-stage designs for binary endpoints and their time-to-event analogues, including the restricted-Kwak and Jung method, rely on a fixed historical benchmark. In practice, historical benchmarks are often uncertain due to small samples, population heterogeneity, changing eligibility criteria, and evolving standards of care. When the clinically relevant benchmark exceeds the value used to...

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Literature Corpus work: f43a8fe1-c51f-5507-a69d-bbbe8ba9b427
DOI: 10.64898/2026.05.14.26353210

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