{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T02:56:33Z","timestamp":1782442593702,"version":"3.54.5"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2019,11,11]],"date-time":"2019-11-11T00:00:00Z","timestamp":1573430400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biometrics"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In this paper, we propose a Bayesian design framework for a biosimilars clinical program that entails conducting concurrent trials in multiple therapeutic indications to establish equivalent efficacy for a proposed biologic compared to a reference biologic in each indication to support approval of the proposed biologic as a biosimilar. Our method facilitates information borrowing across indications through the use of a multivariate normal correlated parameter prior (CPP), which is constructed from easily interpretable hyperparameters that represent direct statements about the equivalence hypotheses to be tested.\u00a0The CPP accommodates different endpoints and data types across indications (eg, binary and continuous) and can, therefore, be used in a wide context of models without having to modify the data (eg, rescaling) to provide reasonable information\u2010borrowing properties. We illustrate how one can evaluate the design using Bayesian versions of the type I error rate and power with the objective of determining the sample size required for each indication such that the design has high power to demonstrate equivalent efficacy in each indication, reasonably high power to demonstrate equivalent efficacy simultaneously in all indications (ie, globally), and reasonable type I error control from a Bayesian perspective. We illustrate the method with several examples, including designing biosimilars trials for follicular lymphoma and rheumatoid arthritis using binary and continuous endpoints, respectively.<\/jats:p>","DOI":"10.1111\/biom.13163","type":"journal-article","created":{"date-parts":[[2019,10,21]],"date-time":"2019-10-21T08:37:45Z","timestamp":1571647065000},"page":"630-642","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Bayesian design of biosimilars clinical programs involving multiple therapeutic indications"],"prefix":"10.1093","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4450-6981","authenticated-orcid":false,"given":"Matthew A.","family":"Psioda","sequence":"first","affiliation":[{"name":"Department of Biostatistics University of North Carolina Chapel Hill North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuolung","family":"Hu","sequence":"additional","affiliation":[{"name":"Biometrics Ionis Pharmaceuticals Inc Carlsbad California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Biostatistics Atara Biotherapeutics Inc Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Pan","sequence":"additional","affiliation":[{"name":"Global Development, Biosimilars, Biostatistics Amgen Inc Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph G.","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of North Carolina Chapel Hill North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,11,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2014.919933"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2011.29.15_suppl.e13064"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2011.01561.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/biom.12215"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518755122"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V128.22.1807.1807"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-017-0226-5"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/rssc.12204"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2011.01679.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.35.15_suppl.7532"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2017.06.009"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/02729890122062514"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7846"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxy009"},{"key":"e_1_2_10_16_1","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2016"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1399"},{"key":"e_1_2_10_18_1","unstructured":"U.S. Food and Drug Administration. (2015) Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. U.S. Food and Drug Administration."},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1214\/ss\/1030550861"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209540"}],"container-title":["Biometrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/biom.13163","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/biom.13163","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/biom.13163","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,26]],"date-time":"2024-01-26T18:09:02Z","timestamp":1706292542000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/biometrics\/article\/76\/2\/630-642\/7452950"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,11]]},"references-count":19,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,6]]}},"alternative-id":["10.1111\/biom.13163"],"URL":"https:\/\/doi.org\/10.1111\/biom.13163","archive":["Portico"],"relation":{},"ISSN":["0006-341X","1541-0420"],"issn-type":[{"value":"0006-341X","type":"print"},{"value":"1541-0420","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,11]]},"assertion":[{"value":"2018-09-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}