{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T08:10:00Z","timestamp":1790151000745,"version":"4.0.1"},"reference-count":39,"publisher":"Wiley","issue":"20-22","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Non\u2010inferiority trials play a central role in clinical research by demonstrating that an experimental treatment is not unacceptably worse than an established reference treatment when superiority is unlikely, but the new treatment offers other advantages, such as reduced toxicity, easier administration, lower cost, or improved adherence. These trials are typically designed as active control studies, making historical data from previous clinical trials or real\u2010world evidence readily available. A key challenge, however, is how to appropriately incorporate multiple heterogeneous historical datasets into the design and analysis of a non\u2010inferiority trial, as each source may differ in relevance, quality, and similarity to the current study. Moreover, a conventional two\u2010arm non\u2010inferiority trial lacks a placebo or standard of care control, requiring the reference treatment effect to be justified using external evidence. When ethically and practically feasible, including a placebo arm allows assessment of assay sensitivity and provides internal validation of the reference treatment effect, thereby strengthening the credibility of the non\u2010inferiority conclusion. In this article, we propose two novel Bayesian self\u2010adapting priors, the Additive Self\u2010Adapting Mixture (ASAM) prior and the Cumulative Self\u2010Adapting Product (CSAP) prior, to incorporate information from multiple historical reference and placebo studies in three\u2010arm non\u2010inferiority trials. The ASAM prior constructs study\u2010specific priors and combines them through an adaptively weighted mixture, whereas the CSAP prior uses a cumulative product formulation with adaptive study\u2010specific weights. Both approaches dynamically borrow information by assigning greater weight to historical studies that are more compatible with the current trial while down\u2010weighting less comparable studies, thereby mitigating the impact of between\u2010study heterogeneity. Extensive simulation studies demonstrate that the proposed methods maintain appropriate control of the Type I error rate while achieving substantial gains in statistical power, providing a flexible and robust framework for Bayesian analysis of three\u2010arm non\u2010inferiority trials.<\/jats:p>","DOI":"10.1002\/sim.70706","type":"journal-article","created":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T08:04:56Z","timestamp":1788249896000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Self\u2010Adapting Priors for Dynamic Borrowing in Three\u2010Arm Non\u2010Inferiority Trials With Pre\u2010Specified Margin"],"prefix":"10.1002","volume":"45","author":[{"given":"Yuansong","family":"Zhao","sequence":"first","affiliation":[{"name":"Department of Biostatistics and Data Science The University of Texas Health Science Center  Houston Texas 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"}]},{"given":"Ram","family":"Tiwari","sequence":"additional","affiliation":[{"name":"Global Stat Solutions  Reston Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3117-7055","authenticated-orcid":false,"given":"Samiran","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science The University of Texas Health Science Center  Houston Texas USA"},{"name":"Institute for Implementation Science The University of Texas Health Science Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/CVM\u20101\u20101\u2010019"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1086\/591390"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.512"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/add.12440"},{"key":"e_1_2_10_6_1","unstructured":"US Food and Drug Administration \u201cNon\u2010Inferiority Clinical Trials to Establish Effectiveness \u201d(2016) . Guidance Document."},{"key":"e_1_2_10_7_1","unstructured":"European Medicines Agency \u201cGuideline on the Choice of the Non\u2010Inferiority Margin \u201d(2006). 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