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After identifying a safe dose range through phase I studies, conducting a multidose randomized trial becomes an effective approach to achieve this objective. However, there have been limited formal statistical designs for such multidose trials, and dose selection in practice is often ad hoc, relying on descriptive statistics. We propose a Bayesian optimal two\u2010stage design to facilitate rigorous dose monitoring and optimization. Utilizing a flexible Bayesian dynamic linear model for the dose\u2013response relationship, we employ dual criteria to assess dose admissibility and desirability. Additionally, we introduce a triple\u2010outcome trial decision procedure to consider dose selection beyond clinical factors. Under the proposed model and decision rules, we develop a systematic calibration algorithm to determine the sample size and Bayesian posterior probability cutoffs to optimize specific design operating characteristics. Furthermore, we demonstrate how to concurrently assess toxicity and efficacy within the proposed framework using a utility\u2010based risk\u2010benefit trade\u2010off. To validate the effectiveness of our design, we conduct extensive simulation studies across a variety of scenarios, demonstrating its robust operating characteristics.<\/jats:p>","DOI":"10.1002\/sim.70090","type":"journal-article","created":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T09:46:08Z","timestamp":1747734368000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["TODO: A Triple\u2010Outcome Double\u2010Criterion Optimal Design for Dose Monitoring\u2010and\u2010Optimization in Multi\u2010Dose Randomized Trials"],"prefix":"10.1002","volume":"44","author":[{"given":"Jingyi","family":"Zhang","sequence":"first","affiliation":[{"name":"Research Center of Biostatistics and Computational Pharmacy China Pharmaceutical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heng","family":"Zhou","sequence":"additional","affiliation":[{"name":"Biostatistics and Research Decision Sciences Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nolan A.","family":"Wages","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zifang","family":"Guo","sequence":"additional","affiliation":[{"name":"Biostatistics and Research Decision Sciences Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Liu","sequence":"additional","affiliation":[{"name":"Biostatistics and Research Decision Sciences Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Jemielita","sequence":"additional","affiliation":[{"name":"Biostatistics and Research Decision Sciences Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3347-5021","authenticated-orcid":false,"given":"Fangrong","family":"Yan","sequence":"additional","affiliation":[{"name":"Research Center of Biostatistics and Computational Pharmacy China Pharmaceutical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2244-131X","authenticated-orcid":false,"given":"Ruitao","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Biostatistics The University of Texas MD Anderson Cancer Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,19]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2109826"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2023.1144056"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6894"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31577"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2022.2080694"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30576-X"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41408-019-0196-6"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30788-0"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0197-2456(00)00115-X"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2824"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1746"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518770661"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2296"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7226"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1191\/1740774505cn094oa"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.198"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774510361541"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/193229681200600609"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4099"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.5467"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280213477767"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280217695579"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200410081"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200510289"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200800190"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2020.09.002"},{"issue":"11","key":"e_1_2_11_28_1","first-page":"1721","article-title":"Two\u2010Stage Plans for Patient Accrual in Phase II Cancer Clinical Trials","volume":"63","author":"Lee Y. 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