{"paper":{"title":"A New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Chemotherapies","license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","headline":"","cross_cats":["stat.AP"],"primary_cat":"stat.ME","authors_text":"Balasubramanian Narasimhan, Jay Bartroff, Tze Leung Lai","submitted_at":"2014-02-11T16:27:30Z","abstract_excerpt":"Recently there has been much work on early phase cancer designs that incorporate both toxicity and efficacy data, called Phase I-II designs because they combine elements of both phases. However, they do not explicitly address the Phase II hypothesis test of $H_0: p\\le p_0$, where $p$ is the probability of efficacy at the estimated maximum tolerated dose (MTD) $\\widehat{\\eta}$ from Phase I and $p_0$ is the baseline efficacy rate. Standard practice for Phase II remains to treat $p$ as a fixed, unknown parameter and to use Simon's 2-stage design with all patients dosed at $\\widehat{\\eta}$. We pro"},"claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"1402.2550","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":""},"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"}