{"paper":{"title":"A Globally Calibrated Bayesian Optimal Phase II Design for Adaptive Enrichment Trials","license":"http://creativecommons.org/licenses/by/4.0/","headline":"","cross_cats":[],"primary_cat":"stat.ME","authors_text":"Hisato Sunami, Masaaki Kuriki, Masahiro Kojima","submitted_at":"2026-07-20T08:40:33Z","abstract_excerpt":"Adaptive enrichment can allow the development of an experimental treatment to continue when its activity is insufficient in an all-comer population but remains promising in a prespecified biomarker-positive subgroup. However, a straightforward sequential application of separately calibrated phase II designs to the two populations can inflate the probability of a false-positive efficacy conclusion. The Bayesian optimal phase II (BOP2) design uses posterior-probability thresholds for interim futility monitoring and final efficacy decisions in single-arm phase II trials. We develop a pathwise glo"},"claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"2607.17692","kind":"arxiv","version":1},"verdict":{"id":null,"model_set":{},"created_at":null,"strongest_claim":"","one_line_summary":"","pipeline_version":null,"weakest_assumption":"","pith_extraction_headline":""},"integrity":{"clean":true,"summary":{"advisory":0,"critical":0,"by_detector":{},"informational":0},"endpoint":"/pith/2607.17692/integrity.json","findings":[],"available":true,"detectors_run":[],"snapshot_sha256":"c28c3603d3b5d939e8dc4c7e95fa8dfce3d595e45f758748cecf8e644a296938"},"references":{"count":0,"sample":[],"resolved_work":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57","internal_anchors":0},"formal_canon":{"evidence_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"author_claims":{"count":0,"strong_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"builder_version":"pith-number-builder-2026-05-17-v1"}