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At every cut\u2010point value, our method gives confidence intervals not only for the efficacy at that cut\u2010point value, but also efficacies in the marker\u2010positive and marker\u2010negative subgroups defined by that cut\u2010point. These confidence intervals are given simultaneously for all possible cut\u2010point values. Using Alzheimer's disease (AD) and type 2 diabetes (T2DM) as examples, we show our method achieves the four principles. Our method <jats:italic>strongly<\/jats:italic> controls familywise type I error rate (FWER) across both levels of multiplicity: the multiplicity of having marker\u2010positive and marker\u2010negative subgroups at each cut\u2010point, and the multiplicity of searching through infinitely many cut\u2010points. This is in contrast to other available methods. The confidence level of our simultaneous confidence intervals is in fact <jats:italic>exact<\/jats:italic> (not conservative). An application (app) is available, which implements the method we propose.<\/jats:p>","DOI":"10.1002\/bimj.202000159","type":"journal-article","created":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T09:34:39Z","timestamp":1614332079000},"page":"272-289","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Exact simultaneous confidence intervals for logical selection of a biomarker cut\u2010point"],"prefix":"10.1002","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4143-7765","authenticated-orcid":false,"given":"Yang","family":"Han","sequence":"first","affiliation":[{"name":"Department of Mathematics University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szu\u2010Yu","family":"Tang","sequence":"additional","affiliation":[{"name":"Roche Tissue Diagnostics  Oro Valley AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui\u2010Min","family":"Lin","sequence":"additional","affiliation":[{"name":"Blueprint Medicines  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason C.","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Statistics Ohio State University  Columbus OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,2,26]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6822"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/0167-9473(88)90017-5"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4899-7180-7"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2307\/2670167"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djm022"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1198\/jasa.2011.tm10067"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.201800002"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4289"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1201\/b10289"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/19466315.2016.1206486"},{"key":"e_1_2_11_12_1","unstructured":"MacDougall J.(2006).Dose finding in drug development. 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