{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:58:38Z","timestamp":1786985918054,"version":"build-2736575974"},"reference-count":17,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T00:00:00Z","timestamp":1752192000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MC_UU_00004\/09"],"award-info":[{"award-number":["MC_UU_00004\/09"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MC_UU_00004\/04"],"award-info":[{"award-number":["MC_UU_00004\/04"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["1R25AI147375"],"award-info":[{"award-number":["1R25AI147375"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100025931","name":"Toe River Arts Council","doi-asserted-by":"publisher","award":["P30AI168440"],"award-info":[{"award-number":["P30AI168440"]}],"id":[{"id":"10.13039\/100025931","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009139","name":"Deutsches Zentrum f\u00fcr Infektionsforschung","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009139","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010767","name":"Innovative Medicines Initiative","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100010767","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010661","name":"Horizon 2020 Framework Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010661","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008069","name":"University of California, San Francisco","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013322","name":"European Federation of Pharmaceutical Industries and Associations","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2025,8]]},"DOI":"10.1016\/j.cct.2025.108002","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T19:27:29Z","timestamp":1752607649000},"page":"108002","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"special_numbering":"C","title":["Designing a response-over-continuous-intervention (ROCI) randomised trial: Implementation in the Phase 2C part (duration ranging) of the PARADIGM4TB trial"],"prefix":"10.1016","volume":"155","author":[{"given":"Tra My","family":"Pham","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela M.","family":"Crook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Rolfe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick P.J.","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne M.","family":"Dufault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Quartagno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2025.108002_bb0005","author":"World Health Organization"},{"key":"10.1016\/j.cct.2025.108002_bb0010","author":"World Health Organization"},{"key":"10.1016\/j.cct.2025.108002_bb0015","first-page":"1","article-title":"Rethinking intercurrent events in defining estimands for tuberculosis trials","author":"Pham","year":"2022","journal-title":"Clin. Trials"},{"key":"10.1016\/j.cct.2025.108002_bb0020","doi-asserted-by":"crossref","first-page":"1577","DOI":"10.1056\/NEJMoa1407426","article-title":"Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis","volume":"371","author":"Gillespie","year":"2014","journal-title":"N. Engl. J. Med."},{"issue":"13","key":"10.1016\/j.cct.2025.108002_bb0025","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1056\/NEJMoa1811867","article-title":"A trial of a shorter regimen for rifampin-resistant tuberculosis","volume":"380","author":"Nunn","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2025.108002_bb0030","doi-asserted-by":"crossref","DOI":"10.1016\/j.cct.2020.105938","article-title":"High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: study protocol for TBTC study 31\/ACTG A5349 phase 3 clinical trial","volume":"90","author":"Dorman","year":"2020","journal-title":"Contemp Clin Trials"},{"key":"10.1016\/j.cct.2025.108002_bb0035","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1177\/1740774518778027","article-title":"Rethinking non-inferiority: a practical trial design for optimising treatment duration","volume":"15","author":"Quartagno","year":"2018","journal-title":"Clin. Trials"},{"key":"10.1016\/j.cct.2025.108002_bb0040","doi-asserted-by":"crossref","first-page":"644","DOI":"10.1177\/1740774520944377","article-title":"The DURATIONS randomised trial design: estimation targets, analysis methods and operating characteristics","volume":"17","author":"Quartagno","year":"2020","journal-title":"Clin. Trials"},{"key":"10.1016\/j.cct.2025.108002_bb0045","author":"Victor Musiime on behalf of the PediCAP trial team"},{"key":"10.1016\/j.cct.2025.108002_bb0050","doi-asserted-by":"crossref","first-page":"e219","DOI":"10.1016\/S1470-2045(23)00095-5","article-title":"REFINE-lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment","volume":"24","author":"Ghorani","year":"2023","journal-title":"Lancet Oncol."},{"key":"10.1016\/j.cct.2025.108002_bb0055","doi-asserted-by":"crossref","first-page":"886","DOI":"10.5588\/ijtld.21.0515","article-title":"UNITE4TB: A new consortium for clinical drug and regimen development for TB","volume":"25","author":"Boeree","year":"2021","journal-title":"\\Int. J. Tuberculos. Lung Dis."},{"key":"10.1016\/j.cct.2025.108002_bb0060","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1002\/sim.9961","article-title":"A flexible multi-metric Bayesian framework for decision-making in phase II multi-arm multi-stage studies","volume":"43","author":"Dufault","year":"2024","journal-title":"Stat. Med."},{"key":"10.1016\/j.cct.2025.108002_bb0065","doi-asserted-by":"crossref","first-page":"964","DOI":"10.1093\/ije\/28.5.964","article-title":"The use of fractional polynomials to model continuous risk variables in epidemiology","volume":"28","author":"Royston","year":"1999","journal-title":"Int. J. Epidemiol."},{"key":"10.1016\/j.cct.2025.108002_bb0070","doi-asserted-by":"crossref","first-page":"2074","DOI":"10.1002\/sim.8086","article-title":"Using simulation studies to evaluate statistical methods","volume":"38","author":"Morris","year":"2019","journal-title":"Stat. Med."},{"key":"10.1016\/j.cct.2025.108002_bb0075","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.1056\/NEJMoa2033400","article-title":"Four-month rifapentine regimens with or without moxifloxacin for tuberculosis","volume":"384","author":"Dorman","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2025.108002_bb0080","series-title":"ICH harmonised guideline addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials ICH E9(R1)","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use","year":"2019"},{"key":"10.1016\/j.cct.2025.108002_bib91","doi-asserted-by":"crossref","first-page":"180","DOI":"10.1186\/s13063-024-07999-w","article-title":"Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial","volume":"25","author":"Weir","year":"2024","journal-title":"Trials"}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442500196X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442500196X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T18:04:01Z","timestamp":1778868241000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S155171442500196X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":17,"alternative-id":["S155171442500196X"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2025.108002","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2025,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Designing a response-over-continuous-intervention (ROCI) randomised trial: Implementation in the Phase 2C part (duration ranging) of the PARADIGM4TB trial","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2025.108002","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"108002"}}