{"state_type":"pith_open_graph_state","state_version":"1.0","pith_number":"pith:2026:POMYLXPJQ34SHD23PJYSJTPROH","merge_version":"pith-open-graph-merge-v1","event_count":2,"valid_event_count":2,"invalid_event_count":0,"equivocation_count":0,"current":{"canonical_record":{"metadata":{"abstract_canon_sha256":"3ac851e57bc65bab83539a7dad2eade59803d248871b0de381ecfa77b9667823","cross_cats_sorted":["stat.ME"],"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2026-03-16T20:23:16Z","title_canon_sha256":"5df9df667fcc68ffbd083edfab928bc595124cce3641d95f05707816e24845c8"},"schema_version":"1.0","source":{"id":"2603.15884","kind":"arxiv","version":3}},"source_aliases":[{"alias_kind":"arxiv","alias_value":"2603.15884","created_at":"2026-06-30T02:17:18Z"},{"alias_kind":"arxiv_version","alias_value":"2603.15884v3","created_at":"2026-06-30T02:17:18Z"},{"alias_kind":"doi","alias_value":"10.48550/arxiv.2603.15884","created_at":"2026-06-30T02:17:18Z"},{"alias_kind":"pith_short_12","alias_value":"POMYLXPJQ34S","created_at":"2026-06-30T02:17:18Z"},{"alias_kind":"pith_short_16","alias_value":"POMYLXPJQ34SHD23","created_at":"2026-06-30T02:17:18Z"},{"alias_kind":"pith_short_8","alias_value":"POMYLXPJ","created_at":"2026-06-30T02:17:18Z"}],"graph_snapshots":[{"event_id":"sha256:20c341922614c53f5a704af45bed802be28f302072c45caf581ca99ec0ae8ca3","target":"graph","created_at":"2026-06-30T02:17:18Z","signer":{"key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signer_id":"pith.science","signer_type":"pith_registry"},"payload":{"graph_snapshot":{"author_claims":{"count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57","strong_count":0},"builder_version":"pith-number-builder-2026-05-17-v1","claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"formal_canon":{"evidence_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"integrity":{"available":true,"clean":true,"detectors_run":[],"endpoint":"/pith/2603.15884/integrity.json","findings":[],"snapshot_sha256":"c28c3603d3b5d939e8dc4c7e95fa8dfce3d595e45f758748cecf8e644a296938","summary":{"advisory":0,"by_detector":{},"critical":0,"informational":0}},"paper":{"abstract_excerpt":"The FDA's Project Optimus initiative emphasizes patient-centered dose selection in oncology that balances efficacy and safety. We develop a framework for randomized dose optimization studies that uses clinically interpretable utility scores to integrate binary efficacy and safety endpoints and select the optimal dose for a follow-on confirmatory trial. The framework provides: (i) a systematic method for eliciting utility scores that reflect clinical priorities; (ii) closed-form sample size formulas to achieve prespecified Probabilities of Correct Selection (PCS) under clinically relevant scena","authors_text":"Cong Xu, Lei Xu, Xuemin Gu, Ying Yuan","cross_cats":["stat.ME"],"headline":"","license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2026-03-16T20:23:16Z","title":"A Utility Score Framework for Dose Optimization Studies with Binary Efficacy-Safety Endpoints: Sample Size Determination and Bias Characterization"},"references":{"count":0,"internal_anchors":0,"resolved_work":0,"sample":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"2603.15884","kind":"arxiv","version":3},"verdict":{"created_at":null,"id":null,"model_set":{},"one_line_summary":"","pipeline_version":null,"pith_extraction_headline":"","strongest_claim":"","weakest_assumption":""}},"verdict_id":null}}],"author_attestations":[],"timestamp_anchors":[],"storage_attestations":[],"citation_signatures":[],"replication_records":[],"corrections":[],"mirror_hints":[],"record_created":{"event_id":"sha256:6bb0106c32559d50c91d702934f6b7d0e3032e583f17d36908d0d3ac95627ff5","target":"record","created_at":"2026-06-30T02:17:18Z","signer":{"key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signer_id":"pith.science","signer_type":"pith_registry"},"payload":{"attestation_state":"computed","canonical_record":{"metadata":{"abstract_canon_sha256":"3ac851e57bc65bab83539a7dad2eade59803d248871b0de381ecfa77b9667823","cross_cats_sorted":["stat.ME"],"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2026-03-16T20:23:16Z","title_canon_sha256":"5df9df667fcc68ffbd083edfab928bc595124cce3641d95f05707816e24845c8"},"schema_version":"1.0","source":{"id":"2603.15884","kind":"arxiv","version":3}},"canonical_sha256":"7b9985dde986f9238f5b7a7124cdf171f86c59b13b1a14d051ef73c249a68389","receipt":{"algorithm":"ed25519","builder_version":"pith-number-builder-2026-05-17-v1","canonical_sha256":"7b9985dde986f9238f5b7a7124cdf171f86c59b13b1a14d051ef73c249a68389","first_computed_at":"2026-06-30T02:17:18.303091Z","key_id":"pith-v1-2026-05","kind":"pith_receipt","last_reissued_at":"2026-06-30T02:17:18.303091Z","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","receipt_version":"0.3","signature_b64":"A5LN3fwH672q3GE5IQA2d+BQSh856KhZRIoAxYXbrFGg/76aWh5rgDNwBQX6ETRYgMP2LEhMcDEuwYHpWzbCAA==","signature_status":"signed_v1","signed_at":"2026-06-30T02:17:18.303832Z","signed_message":"canonical_sha256_bytes"},"source_id":"2603.15884","source_kind":"arxiv","source_version":3}}},"equivocations":[],"invalid_events":[],"applied_event_ids":["sha256:6bb0106c32559d50c91d702934f6b7d0e3032e583f17d36908d0d3ac95627ff5","sha256:20c341922614c53f5a704af45bed802be28f302072c45caf581ca99ec0ae8ca3"],"state_sha256":"2b35a75c10a508395c0b14caf8736ae260269ddc2d620af97f5723265ed50bd1"}