{"paper":{"title":"A Practical Framework for Sensitivity Analysis in Externally Controlled Trials: An Illustration with a Bayesian Hybrid Evidence Synthesis Case Study","license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","headline":"","cross_cats":["stat.AP"],"primary_cat":"stat.ME","authors_text":"Jane Zhang, Kitty Guo, Xuemin Gu","submitted_at":"2026-06-07T14:14:50Z","abstract_excerpt":"Externally controlled trials (ECTs), including single-arm studies augmented with historical data and hybrid randomized designs with partial external augmentation, are increasingly used when concurrent randomized controls are infeasible or unethical. Regulatory guidance from the FDA, EMA, and NMPA calls for sensitivity analysis of borrowing assumptions, yet provides no structured template for which analyses to run or how to interpret them together.\n  We propose a three-pillar framework organized around three questions: was the borrowing appropriate, did it contribute meaningful value, and are t"},"claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"2606.08642","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/2606.08642/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"}