{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,27]],"date-time":"2025-08-27T16:14:21Z","timestamp":1756311261418,"version":"3.37.3"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T00:00:00Z","timestamp":1541030400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2018,11]]},"DOI":"10.1177\/2168479018759660","type":"journal-article","created":{"date-parts":[[2018,3,6]],"date-time":"2018-03-06T01:53:34Z","timestamp":1520301214000},"page":"690-695","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety"],"prefix":"10.1007","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2762-242X","authenticated-orcid":false,"given":"Jiacheng","family":"Yuan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Mesenbrink","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jihao","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeen","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ray","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Koch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,12,30]]},"reference":[{"key":"5206690_CR1","doi-asserted-by":"publisher","first-page":"586","DOI":"10.1002\/sim.3495","volume":"28","author":"F Bretz","year":"2009","unstructured":"Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective multiple test procedures. Stat Med. 2009;28:586\u2013604.","journal-title":"Stat Med"},{"key":"5206690_CR2","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1080\/19466315.2013.807748","volume":"5","author":"W Maurer","year":"2013","unstructured":"Maurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. Stat Biopharm Res. 2013;5:311\u2013320.","journal-title":"Stat Biopharm Res"},{"key":"5206690_CR3","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1002\/bimj.201300157","volume":"57","author":"D Xi","year":"2015","unstructured":"Xi D, Tamhane AC. Allocating recycled significance levels in group sequential procedures for multiple endpoints. Biomet J. 2015;57:90\u2013107.","journal-title":"Biomet J"},{"key":"5206690_CR4","unstructured":"FDA. Guidance for industry: Providing Clinical Evidence and Effectiveness for Human Drug and Biologic Products. 1998."},{"key":"5206690_CR5","first-page":"1","volume-title":"Recent Advances in Clinical Trial Design and Analysis","author":"DL DeMets","year":"1995","unstructured":"DeMets DL, Lan G. The alpha spending function approach to interim data analyses. In: Thrall PF, ed. Recent Advances in Clinical Trial Design and Analysis. Boston, MA: Kluwer Academic; 1995:1\u201327."},{"key":"5206690_CR6","doi-asserted-by":"publisher","first-page":"1112","DOI":"10.1002\/sim.5700","volume":"32","author":"Y Ye","year":"2013","unstructured":"Ye Y, Li A, Liu L, Yao B. A group sequential Holm procedure with multiple primary endpoints. Stat Med. 2013;32:1112\u20131124.","journal-title":"Stat Med"},{"key":"5206690_CR7","doi-asserted-by":"publisher","first-page":"549","DOI":"10.2307\/2530245","volume":"35","author":"PC O\u2019Brien","year":"1979","unstructured":"O\u2019Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549\u2013556.","journal-title":"Biometrics"},{"key":"5206690_CR8","unstructured":"FDA Guidance to Industry. Diabetes mellitus\u2014Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm071627.pdf. Published 2008."},{"key":"5206690_CR9","volume-title":"East Version 6.4: User Manual","author":"Cytel Statistical Software","year":"2016","unstructured":"Cytel Statistical Software. East Version 6.4: User Manual. Cambridge, MA: Cytel Software Corporation; 2016."},{"key":"5206690_CR10","volume-title":"PASS 2008 User\u2019s Guide","author":"JL Hintz","year":"2008","unstructured":"Hintz JL. PASS 2008 User\u2019s Guide. Kaysville, UT: NCSS; 2008."},{"key":"5206690_CR11","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1002\/pst.17","volume":"2","author":"U Munzel","year":"2003","unstructured":"Munzel U, Hauschke D. A nonparametric test for proving noninferiority in clinical trials with ordered categorical data. Pharm Stat. 2003;2:31\u201337.","journal-title":"Pharm Stat"},{"key":"5206690_CR12","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1002\/pst.1799","volume":"16","author":"H Sun","year":"2017","unstructured":"Sun H, Kawaguchi A, Koch GG. Analyzing multiple endpoints in a confirmatory randomized clinical trial\u2014an approach that addresses stratification, missing values, baseline imbalance and multiplicity for strictly ordinal outcomes. Pharm Stat. 2017;16:157\u2013166.","journal-title":"Pharm Stat"},{"key":"5206690_CR13","doi-asserted-by":"publisher","first-page":"1329","DOI":"10.1056\/NEJMoa1412679","volume":"373","author":"PJ Mease","year":"2015","unstructured":"Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab inhibition of interleukin-17a in patients with psoriatic arthritis. N Engl J Med. 2015;373:1329\u20131339.","journal-title":"N Engl J Med"},{"key":"5206690_CR14","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1002\/art.22379","volume":"56","author":"DD Gladman","year":"2007","unstructured":"Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56:476\u2013488.","journal-title":"Arthritis Rheum"},{"key":"5206690_CR15","doi-asserted-by":"publisher","first-page":"1914","DOI":"10.1002\/art.39685","volume":"68","author":"D Heijde van der","year":"2016","unstructured":"van der Heijde D, Landew\u00e9 RB, Mease PJ, et al. Brief report: secukinumab provides significant and sustained inhibition of joint structural damage in a phase III study of active psoriatic arthritis. Arthritis Rheumatol. 2016;68:1914\u20131921.","journal-title":"Arthritis Rheumatol"}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018759660.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2168479018759660","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1177\/2168479018759660\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2168479018759660","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018759660.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T13:07:54Z","timestamp":1598015274000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1177\/2168479018759660"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11]]},"references-count":15,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,11]]}},"alternative-id":["5206690"],"URL":"https:\/\/doi.org\/10.1177\/2168479018759660","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"type":"print","value":"2168-4790"},{"type":"electronic","value":"2168-4804"}],"subject":[],"published":{"date-parts":[[2018,11]]},"assertion":[{"value":"14 September 2017","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 January 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 December 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}]}}