{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T09:49:37Z","timestamp":1791539377076,"version":"4.3.4"},"reference-count":52,"publisher":"Wiley","issue":"23-24","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["P50CA281701"],"award-info":[{"award-number":["P50CA281701"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["P50CA127001"],"award-info":[{"award-number":["P50CA127001"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["U24CA274212"],"award-info":[{"award-number":["U24CA274212"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Bridging studies serve as an efficient approach to evaluate the applicability of findings from an original study to a new population. We propose a Bayesian adaptive design for bridging studies with time\u2010to\u2010event endpoints, aiming to assess the consistency of treatment effects with those observed in the original study. The design adopts a group sequential framework, using posterior probabilities at interim and final analyses to evaluate the evidence for consistency between the bridging and original studies. If strong evidence of consistency or inconsistency is observed, the trial may be stopped early to conserve sample size. Additionally, a sample size recalculation strategy based on Bayesian predictive probability is incorporated to enhance flexibility. Simulation studies demonstrate that, compared to a commonly used method, the proposed design offers favorable operating characteristics. It maintains control of the empirical type I error rate through prespecified calibration, accounting for interim analyses (IAs) and sample size adaptation, and yields substantial sample size savings when the treatment effect in the bridging study is either highly consistent or clearly inconsistent with that of the original study.<\/jats:p>","DOI":"10.1002\/sim.70749","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T07:15:43Z","timestamp":1790752543000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Bayesian Adaptive Design for Assessing Treatment Effect Consistency in Bridging Studies"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-1038-5003","authenticated-orcid":false,"given":"Xinyi","family":"He","sequence":"first","affiliation":[{"name":"Department of Biostatistics The University of Texas MD Anderson Cancer Center  Houston Texas USA"},{"name":"Graduate School of Biomedical Sciences The University of Texas Health Science Center at Houston  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3761-7090","authenticated-orcid":false,"given":"Dan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Global Biometrics Servier Pharmaceuticals  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaoyang","family":"Teng","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Liu","sequence":"additional","affiliation":[{"name":"Global Biometrics Servier Pharmaceuticals  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3163-480X","authenticated-orcid":false,"given":"Ying","family":"Yuan","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":[[2026,9,30]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"ICH International Conference on Harmonisation \u201cTripartite Guidance E5: Ethnic Factors in the Acceptability of Foreign Data \u201dThe U.S. Federal Register (1998)."},{"key":"e_1_2_10_3_1","unstructured":"U.S. Food and Drug Administration \u201cGuidance for Industry: E5 Ethnic Factors in the Acceptability of Foreign Clinical Data \u201d(2006) https:\/\/www.fda.gov\/media\/71293\/download."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-200062284"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-200040836"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1201\/b12277"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543401003618900"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2012.702651"},{"key":"e_1_2_10_9_1","unstructured":"Ministry of Health Labour and Welfare \u201cBasic Principles on Global Clinical Trials \u201dNotification No. 0928010 (2007) https:\/\/www.pmda.go.jp\/files\/000153265.pdf."},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2012.701580"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200290008"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2013.05.006"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.438"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4251"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2012.701579"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-021-00280-1"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2304194"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2307\/2531021"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.2307\/2983527"},{"issue":"1","key":"e_1_2_10_20_1","first-page":"156","article-title":"Incorporating Bayesian Ideas Into Healthcare Evaluation","volume":"19","author":"Spiegelhalter D.","year":"2004","journal-title":"Statistical Science \u2010 STAT SCI"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1989.10478874"},{"key":"e_1_2_10_22_1","unstructured":"U.S. Food and Drug Administration \u201cAdaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry \u201d(2019)."},{"key":"e_1_2_10_23_1","unstructured":"U.S. Food and Drug Administration \u201cUse of Bayesian Methodology in Clinical Trials of Drug and Biological Products \u201d(2026) https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/use\u2010bayesian\u2010methodology\u2010clinical\u2010trials\u2010drug\u2010and\u2010biological\u2010products."},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7338"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.2307\/2533262"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.00853.x"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19990715)18:13<1575::AID-SIM153>3.0.CO;2-Z"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.01286.x"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19991230)18:24<3481::AID-SIM301>3.0.CO;2-C"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-13-94"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1688"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4102"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.5691\/jjb.29.19"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1995.10476592"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/68.1.316"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1214\/aos\/1176346505"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1982.10477898"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70420-6"},{"key":"e_1_2_10_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(21)00313-7"},{"key":"e_1_2_10_40_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1704795"},{"key":"e_1_2_10_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(19)30053-0"},{"key":"e_1_2_10_42_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.0000000000000323"},{"key":"e_1_2_10_43_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2004"},{"key":"e_1_2_10_44_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774519871447"},{"key":"e_1_2_10_45_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4274"},{"key":"e_1_2_10_46_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.55.2208"},{"key":"e_1_2_10_47_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djv156"},{"key":"e_1_2_10_48_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.08.1034"},{"key":"e_1_2_10_49_1","doi-asserted-by":"publisher","DOI":"10.1177\/09622802241304111"},{"key":"e_1_2_10_50_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxt016"},{"key":"e_1_2_10_51_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2864"},{"key":"e_1_2_10_52_1","doi-asserted-by":"publisher","DOI":"10.1111\/biom.13927"},{"key":"e_1_2_10_53_1","doi-asserted-by":"publisher","DOI":"10.1214\/ss\/1009212673"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70749","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/sim.70749","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70749","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T09:00:11Z","timestamp":1791536411000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.70749"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,30]]},"references-count":52,"journal-issue":{"issue":"23-24","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/sim.70749"],"URL":"https:\/\/doi.org\/10.1002\/sim.70749","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,30]]},"assertion":[{"value":"2026-04-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70749"}}