{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:17:20Z","timestamp":1791940640668,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,10]],"date-time":"2024-11-10T00:00:00Z","timestamp":1731196800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["P30CA142543"],"award-info":[{"award-number":["P30CA142543"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceutical Statistics"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>With the development of targeted therapy, immunotherapy, and antibody\u2010drug conjugates (ADCs), there is growing concern over the \u201cmore is better\u201d paradigm developed decades ago for chemotherapy, prompting the US Food and Drug Administration (FDA) to initiate Project Optimus to reform dose optimization and selection in oncology drug development. For early\u2010phase oncology trials, given the high variability from sparse data and the rigidity of parametric model specifications, we use Bayesian dynamic models to borrow information across doses with only vague order constraints. Our proposed adaptive design simultaneously incorporates toxicity and efficacy outcomes to select the optimal dose (OD) in Phase I\/II clinical trials, utilizing Bayesian model averaging to address the uncertainty of dose\u2013response relationships and enhance the robustness of the design. Additionally, we extend the proposed design to handle delayed toxicity and efficacy outcomes. We conduct extensive simulation studies to evaluate the operating characteristics of the proposed method under various practical scenarios. The results demonstrate that the proposed designs have desirable operating characteristics. A trial example is presented to demonstrate the practical implementation of the proposed designs.<\/jats:p>","DOI":"10.1002\/pst.2451","type":"journal-article","created":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T06:14:20Z","timestamp":1731305660000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A Bayesian Dynamic Model\u2010Based Adaptive Design for Oncology Dose Optimization in Phase I\/<scp>II<\/scp> Clinical Trials"],"prefix":"10.1002","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-9429-2131","authenticated-orcid":false,"given":"Yingjie","family":"Qiu","sequence":"first","affiliation":[{"name":"Peter O'Donnell Jr. School of Public Health University of Texas Southwestern Medical Center  Dallas Texas USA"},{"name":"Harold C. Simmons Comprehensive Cancer Center University of Texas Southwestern Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingyue","family":"Li","sequence":"additional","affiliation":[{"name":"Peter O'Donnell Jr. School of Public Health University of Texas Southwestern Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,11,10]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"U.S. FDA \u201cProject Optimus \u201d(2022) https:\/\/www.fda.gov\/about\u2010fda\/oncology\u2010center\u2010excellence\/project\u2010optimus."},{"key":"e_1_2_9_3_1","unstructured":"U.S. FDA \u201cOptimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases \u201dDraft Guidance for Industry(2023) https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/optimizing\u2010dosage\u2010human\u2010prescription\u2010drugs\u2010and\u2010biological\u2010products\u2010treatment\u2010oncologic\u2010diseases."},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12540"},{"key":"e_1_2_9_5_1","first-page":"1307","article-title":"Experimental Evaluation of Potential Anticancer Agents. 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