{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T05:53:33Z","timestamp":1790142813516,"version":"4.0.1"},"reference-count":45,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T00:00:00Z","timestamp":1748217600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T00:00:00Z","timestamp":1748217600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    Real\u2010world data (RWD) previously contributed to post\u2010marketing regulatory decision\u2010making, but are currently also considered as external controls to single\u2010arm trials. The use of RWD control data may be compromised by methodological issues, urging validation of RWD control cohorts. Two external control cohorts of newly diagnosed acute myeloid leukaemia patients, one registered by the HARMONY Alliance (HA) and one by the Netherlands Cancer Registry (NCR), were compared to the control arm of the randomized HOVON\u2010103 trial (H103 controls). All patients, aged &gt;65\u2009years with a WHO performance score of 0\u20132 (or missing), received standard induction chemotherapy. 1:1 propensity score calliper matching (PSM) was applied to improve comparability, and overall (OS) and relapse\u2010free survival (RFS) were assessed. Fewer data elements were available in external cohorts compared to H103 controls, specifically in the NCR cohort. Baseline characteristics of the external cohorts differed from H103 controls; missing data were also more frequent and predominantly concerned WHO performance score. After PSM, HA patients demonstrated non\u2010significantly different OS and RFS to H103 controls at 2\u2009years (26\u2009\u00b1\u20094% vs. 31\u2009\u00b1\u20095%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.59; 24\u2009\u00b1\u20095% vs. 30\u2009\u00b1\u20096%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.52), while NCR patients had 12% lower OS (28\u2009\u00b1\u20094% vs. 40\u2009\u00b1\u20094%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.21). Validation of external control cohorts is needed before incorporating RWD control data into comparative analyses, as missing data, specifically comorbidities, and residual confounding may limit comparability.\n                  <\/jats:p>","DOI":"10.1111\/bjh.20185","type":"journal-article","created":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T20:08:38Z","timestamp":1748290118000},"page":"179-188","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparability of external and internal control patients for the prospective randomized\n                    <scp>HOVON<\/scp>\n                    \u2010103 trial in older\n                    <scp>AML<\/scp>\n                    patients"],"prefix":"10.1111","volume":"208","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3906-4584","authenticated-orcid":false,"given":"Sjoerd J. F.","family":"Hermans","sequence":"first","affiliation":[{"name":"Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jurjen","family":"Versluis","sequence":"additional","affiliation":[{"name":"Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik D.","family":"van Werkhoven","sequence":"additional","affiliation":[{"name":"Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"},{"name":"HOVON Foundation  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvette","family":"van Norden","sequence":"additional","affiliation":[{"name":"Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"},{"name":"HOVON Foundation  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen J. W. M.","family":"Janssen","sequence":"additional","affiliation":[{"name":"Department of Haematology University Medical Centre Nijmegen  Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerwin A.","family":"Huls","sequence":"additional","affiliation":[{"name":"Department of Hematology University Medical Center Groningen (UMCG)  Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6055-5257","authenticated-orcid":false,"given":"Thomas","family":"Pabst","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Inselspital Bern University Hospital  Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitri A.","family":"Breems","sequence":"additional","affiliation":[{"name":"Ziekenhuis Netwerk Antwerpen  Antwerp Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Berkx","sequence":"additional","affiliation":[{"name":"Department of Research and Development Netherlands Comprehensive Cancer Organization (IKNL)  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4767-6716","authenticated-orcid":false,"given":"Avinash G.","family":"Dinmohamed","sequence":"additional","affiliation":[{"name":"Department of Research and Development Netherlands Comprehensive Cancer Organization (IKNL)  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"Huijgens","sequence":"additional","affiliation":[{"name":"Department of Research and Development Netherlands Comprehensive Cancer Organization (IKNL)  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Str\u00e4ng","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology, Tumor Immunology Charit\u00e9 University Medicine  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jes\u00fas Mar\u00eda","family":"Hern\u00e1ndez Rivas","sequence":"additional","affiliation":[{"name":"Servicio de Hematolog\u00eda, Hospital Universitario de Salamanca Universidad de Salamanca  Salamanca Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0781-8668","authenticated-orcid":false,"given":"Marta","family":"Sobas","sequence":"additional","affiliation":[{"name":"Department of Hematology, Blood Neoplasms, and Bone Marrow Transplantation Wroclaw Medical University  Wroclaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2699-8353","authenticated-orcid":false,"given":"Rosa","family":"Ayala Diaz","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital 12 de Octubre (i+12), Centro Nacional de Investigaciones Oncol\u00f3gicas (CNIO) Complutense University  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5904-0902","authenticated-orcid":false,"given":"Joaquin","family":"Martinez Lopez","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital 12 de Octubre (i+12), Centro Nacional de Investigaciones Oncol\u00f3gicas (CNIO) Complutense University  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3920-7490","authenticated-orcid":false,"given":"Klaus H.","family":"Metzeler","sequence":"additional","affiliation":[{"name":"Department of Hematology, Cellular Therapy, Hemostaseology and Infectious Diseases University Medical Center Leipzig  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torsten","family":"Haferlach","sequence":"additional","affiliation":[{"name":"MLL Munich Leukemia Laboratory  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1241-2048","authenticated-orcid":false,"given":"Christian","family":"Thiede","sequence":"additional","affiliation":[{"name":"Department of Medicine I University Hospital Carl Gustav Carus  Dresden Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carin A.","family":"Uyl\u2010de Groot","sequence":"additional","affiliation":[{"name":"Erasmus School of Health Policy &amp; Management Erasmus University Rotterdam  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Bullinger","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology, and Cancer Immunology Charit\u00e9\u2010Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bob","family":"L\u00f6wenberg","sequence":"additional","affiliation":[{"name":"Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gert J.","family":"Ossenkoppele","sequence":"additional","affiliation":[{"name":"Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers Vrije Universiteit University Medical Center  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Pignatti","sequence":"additional","affiliation":[{"name":"Oncology and Hematology Office European Medicines 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