{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T04:07:43Z","timestamp":1788754063078,"version":"build-2803163510"},"reference-count":47,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T00:00:00Z","timestamp":1788652800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T00:00:00Z","timestamp":1788652800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["R01DK138036"],"award-info":[{"award-number":["R01DK138036"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Real\u2010world evidence (RWE) derived from real\u2010world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained\n                    <jats:italic>post hoc<\/jats:italic>\n                    consent and linked individual participant data from the US\u2010based INVESTED trial (2016\u20132019) with Medicare fee\u2010for\u2010service claims (2012\u20132020) to validate demographic factors, baseline characteristics (using 183\u2010, 365\u2010, and 730\u2010day lookback periods) and outcomes, and to assess post\u2010trial events. Among 5260 trial participants, 126 were enrolled and eligible for linkage. Among 115 participants with demographic information available from Medicare enrollment files, agreement between RCT\u2010 and RWD\u2010based demographic factors was high: only one major age discrepancy, 100% agreement for sex, and an overall agreement of 0.89 for race. Participants with Medicare claims data (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200965) were older and more likely to be White compared with the overall RCT population. For the 365\u2010day lookback period, baseline comorbidities showed high sensitivity (median 0.80) and specificity (0.89), as did medication use (sensitivity 1.00, specificity 0.88). Lengthening the lookback period to 730\u2009days increased sensitivity but decreased specificity, whereas shortening to 183\u2009days decreased sensitivity but increased specificity. Clinical outcomes showed high specificity (0.88\u20130.94) but low sensitivity (0.18\u20130.50). Among those with Medicare coverage beyond the trial end date (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200945), 22% experienced cardiopulmonary, 18% cardiovascular, and 7% heart failure (HF) hospitalizations, highlighting the value of RWD for extending RCT evidence. Proactive planning of future RCT\u2010RWD linkage initiatives can improve the efficiency of linkage studies, leading to more actionable results.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70457","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T03:15:22Z","timestamp":1788750922000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real\u2010World Data: The INVESTED\u2010Medicare Linkage Study"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7463-4094","authenticated-orcid":false,"given":"Hanseul","family":"Cho","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Division of General Internal Medicine &amp; Health Services Research, Department of Medicine David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2032-6134","authenticated-orcid":false,"given":"HoJin","family":"Shin","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Johnson &amp; Johnson Innovative Medicine  Titusville New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4503-1057","authenticated-orcid":false,"given":"Mehdi","family":"Najafzadeh","sequence":"additional","affiliation":[{"name":"UCB  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4215-9218","authenticated-orcid":false,"given":"Brian","family":"Claggett","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8196-6648","authenticated-orcid":false,"given":"Janinne","family":"Ortega\u2010Montiel","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Division of General Internal Medicine &amp; Health Services Research, Department of Medicine David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Liu","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1315-5445","authenticated-orcid":false,"given":"Julie M.","family":"Paik","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Division of General Internal Medicine &amp; Health Services Research, Department of Medicine David Geffen School of Medicine at UCLA  Los Angeles California USA"},{"name":"Division of Nephrology, Department of Medicine David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3238-3869","authenticated-orcid":false,"given":"Narlina F.","family":"Lalani","sequence":"additional","affiliation":[{"name":"VA Health Care System  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6266-4414","authenticated-orcid":false,"given":"Marie C.","family":"Bradley","sequence":"additional","affiliation":[{"name":"Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2846-0503","authenticated-orcid":false,"given":"John","family":"Concato","sequence":"additional","affiliation":[{"name":"Department of Medicine Yale University School of Medicine  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3698-9597","authenticated-orcid":false,"given":"Scott D.","family":"Solomon","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6387-1351","authenticated-orcid":false,"given":"Orly","family":"Vardeny","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8809-9898","authenticated-orcid":false,"given":"Elisabetta","family":"Patorno","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Division of General Internal Medicine &amp; Health Services Research, Department of Medicine David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,6]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"crossref","first-page":"1680","DOI":"10.1056\/NEJMp2200089","article-title":"Real\u2010world evidence \u2013 where are we now?","volume":"386","author":"Concato J.","year":"2022","journal-title":"N. 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