{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T19:14:22Z","timestamp":1792005262847,"version":"4.4.0"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T00:00:00Z","timestamp":1724716800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01AR080194"],"award-info":[{"award-number":["R01AR080194"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01AG053302"],"award-info":[{"award-number":["R01AG053302"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["RO1HL141505"],"award-info":[{"award-number":["RO1HL141505"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"US Food and Drug Administration","award":["HHSF223201810146C"],"award-info":[{"award-number":["HHSF223201810146C"]}]},{"name":"US Food and Drug Administration","award":["HHSF223201710186C"],"award-info":[{"award-number":["HHSF223201710186C"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Observational studies are increasingly used to provide real-world evidence in regulatory decision-making. The RCT-DUPLICATE initiative conducted observational studies emulating 2 published randomized trials in patients with asthma and 3 in chronic obstructive pulmonary disease (COPD). For each trial, new-user cohorts were constructed from 2 US healthcare claims databases, comparing initiators of the study and comparator drugs, matched on propensity scores. Proportional hazards models were used to compare the treatments on study outcomes. The observational studies involved more subjects than the corresponding trials, with treatment arms well-matched on baseline characteristics. An asthma example involved emulation of the 26-week FDA-mandated D5896 trial. With 6494 asthma patients per arm, the hazard ratio (HR) of a serious asthma-related event with budesonide-formoterol vs budesonide was 1.29 (95% CI, 0.63-2.65) compared with 1.07 (95% CI, 0.70-1.65) in the trial. A COPD example is the emulation of the one-year IMPACT trial. With 4365 COPD patients per arm, the HR of a COPD exacerbation with triple therapy vs dual bronchodilators was 1.08 (95% CI, 1.00-1.17) compared with 0.84 (95% CI, 0.78-0.91) in the trial. We found mainly discordant results between observational analyses and their emulated randomized trials, likely from the forced discontinuation of treatments prior to randomization in the trials, not mimicable in the observational analyses.<\/jats:p>\n               <jats:p>This article is part of a Special Collection on Pharmacoepidemiology.<\/jats:p>","DOI":"10.1093\/aje\/kwae319","type":"journal-article","created":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T02:11:03Z","timestamp":1724811063000},"page":"1152-1159","source":"Crossref","is-referenced-by-count":10,"title":["Emulating randomized trials by observational database studies: the RCT-DUPLICATE initiative in COPD and asthma"],"prefix":"10.1093","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1281-5296","authenticated-orcid":false,"given":"Samy","family":"Suissa","sequence":"first","affiliation":[{"name":"Centre for Clinical Epidemiology, Lady Davis Institute Jewish General Hospital , Montreal, Quebec ,","place":["Canada"]},{"name":"Department of Epidemiology, Biostatistics, and of Medicine, McGill University Montreal , Quebec ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Schneeweiss","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital , 1620 Tremont St Suite 3030, Boston, MA,","place":["United States"]},{"name":"Department of Medicine , Harvard Medical School, Boston, MA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William B","family":"Feldman","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital , 1620 Tremont St Suite 3030, Boston, MA,","place":["United States"]},{"name":"Department of Medicine , Harvard Medical School, Boston, MA,","place":["United States"]},{"name":"Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women\u2019s Hospital ,","place":["15 Francis Street, Boston, MA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Tesfaye","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital , 1620 Tremont St Suite 3030, Boston, MA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7761-7090","authenticated-orcid":false,"given":"Shirley V","family":"Wang","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital , 1620 Tremont St Suite 3030, Boston, MA,","place":["United States"]},{"name":"Department of Medicine , Harvard Medical School, Boston, MA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,8,27]]},"reference":[{"issue":"2","key":"2025050622571783200_ref1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00598-2019","article-title":"The global initiative for asthma (GINA): 25\u00a0years later","volume":"54","author":"Boulet","year":"2019","journal-title":"Eur Respir J."},{"issue":"3","key":"2025050622571783200_ref2","doi-asserted-by":"publisher","first-page":"1700214","DOI":"10.1183\/13993003.00214-2017","article-title":"Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 Report: GOLD executive summary","volume":"49","author":"Vogelmeier","journal-title":"Eur Respir J."},{"issue":"23","key":"2025050622571783200_ref3","doi-asserted-by":"publisher","first-page":"2293","DOI":"10.1056\/NEJMsb1609216","article-title":"Real-world evidence \u2014 what is it and what can it tell us?","volume":"375","author":"Sherman","year":"2016","journal-title":"N Engl J Med."},{"issue":"5","key":"2025050622571783200_ref4","doi-asserted-by":"publisher","first-page":"465","DOI":"10.1056\/NEJMra1614394","article-title":"Evidence for health decision making\u2014beyond randomized, controlled trials","volume":"377","author":"Frieden","year":"2017","journal-title":"N Engl J Med."},{"issue":"4","key":"2025050622571783200_ref5","doi-asserted-by":"publisher","first-page":"773","DOI":"10.1002\/cpt.1638","article-title":"Are novel, nonrandomized analytic methods fit for decision making? 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