{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T08:10:24Z","timestamp":1790151024542,"version":"4.0.1"},"reference-count":42,"publisher":"Wiley","issue":"20-22","license":[{"start":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T00:00:00Z","timestamp":1789344000000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"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"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["25K03086"],"award-info":[{"award-number":["25K03086"]}],"id":[{"id":"10.13039\/501100001691","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":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>It is common practice in randomized clinical trials with the standard survival outcome to follow patients until a prespecified number of events have been observed, a type of trial known as the event\u2010driven trial. The event\u2010driven design ensures that the target power for a specified Type I error rate is achieved to detect the target hazard ratio, regardless of the specification of other quantities. To understand the treatment effect for chronic conditions, the analysis of recurrent events has gained popularity in randomized controlled trials, particularly large\u2010scale confirmatory trials. In the absence of within\u2010subject correlation among multiple events, a similar event\u2010driven design can be employed for recurrent event outcomes. On the other hand, in the presence of within\u2010subject correlation, one needs to model the correlation among recurrent events in evaluating power and setting the sample size. However, information useful in modeling the within\u2010subject correlation is limited at the design stage. Failing to properly account for correlation may lead to underpowered studies. We propose an event\u2010driven type design for recurrent event outcomes. Our method ensures the target power for the target treatment effect, regardless of the specification of other quantities, by monitoring the robust variance under the marginal rates\/means model in a blinded manner. We investigate the operating characteristics of the proposed monitoring procedure in simulation studies. The results of simulation studies showed that the proposed blinded monitoring procedure controlled the power well so that the test possessed the target power and did not lead to serious inflation of the Type I error rate. Furthermore, we illustrate the proposed method using a real clinical trial dataset.<\/jats:p>","DOI":"10.1002\/sim.70742","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T05:21:16Z","timestamp":1789449676000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Event\u2010Driven Type Design for Clinical Trials With Recurrent Events"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2327-8278","authenticated-orcid":false,"given":"Jingwen","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Biomedical Statistics, Graduate School of Medicine The University of Osaka  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0200-1408","authenticated-orcid":false,"given":"Satoshi","family":"Hattori","sequence":"additional","affiliation":[{"name":"Department of Biomedical Statistics, Graduate School of Medicine The University of Osaka  Osaka Japan"},{"name":"Integrated Frontier Research for Medical Science Division Institute for Open and Transdisciplinary Research Initiatives (OTRI), The University of Osaka  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/BIOMET\/68.1.316"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.2307\/2531021"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.1139"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)32339\u20104"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2030186"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.07.024"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.033065"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/PST.2167"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1214\/aos\/1176345976"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/SIM.693"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/IJE\/DYU222"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/1467\u20109868.00259"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.spl.2008.09.016"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2014.919935"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/SIM.4780141903"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2011"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/SIM.8335"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/BIMJ.201300090"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541\u20100420.2011.01589.x"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3645"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.2517-6161.1972.tb00899.x"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4684-6316-3_4"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/00401706.1995.10484300"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1993.10476346"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781118150672"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/J.1541\u20100420.2007.00948.X"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280220921889"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010015\u20100005\u20102"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199102213240801"},{"key":"e_1_2_11_31_1","unstructured":"T. M.Therneau T.Lumley A.Elizabeth andC.Cynthia \u201cPackage \u2018Survival\u2019 \u201d 2024."},{"key":"e_1_2_11_32_1","unstructured":"A.Balan H.Putter andM.Theodor \u201cFitting Frailty Models With the EM Algorithm \u201d 2022."},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.csda.2009.07.012"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010016\u20100117\u20103"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/19466315.2025.2468466"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2022.106999"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1080\/19466315.2026.2681574"},{"key":"e_1_2_11_38_1","unstructured":"U.S. Food and Drug Administration \u201cAdaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry \u201d 2019accessed May 29 2026."},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200510238"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006\u2010341X.1999.00853.x"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4102"},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280218780538"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/70.3.659"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70742","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/sim.70742","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70742","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T07:44:10Z","timestamp":1790149450000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.70742"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":42,"journal-issue":{"issue":"20-22","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/sim.70742"],"URL":"https:\/\/doi.org\/10.1002\/sim.70742","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]]},"assertion":[{"value":"2025-12-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70742"}}