{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T15:08:56Z","timestamp":1789139336138,"version":"build-2803163510"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"3","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Clin Cancer Inform"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Heterogeneity in cancer registries limits reuse of real-world data (RWD) alongside clinical trials to support regulatory decisions. Rituximab, gemcitabine, and oxaliplatin (R-GemOx) is commonly a comparator in large B-cell lymphoma (LBCL) trials and used in practice, but RWD are not structured for trial comparison. We developed a reusable pipeline to convert the Lymphoma Epidemiology of Outcomes Consortium for Real World Evidence (LEO CReWE) registry into Clinical Data Interchange Standards Consortium (CDISC)\u2013compliant data sets by constructing a generalized, registry-wide Study Data Tabulation Model (SDTM) and deriving analysis-ready Analysis Data Model (ADaM) data sets.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Using R 4.5.2 with the sdtm.oak, admiral, and admiralonco packages, we generated ADaM for 183 patients with relapsed\/refractory LBCL treated with R-GemOx across the multicenter LEO cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>ADaM-derived summary statistics showed exact concordance with published results for this cohort: median age 68 years, complete response rate 29%, median overall survival 13.5 months, and median event-free survival 2.3 months. CDISC conformance was assessed using the CDISC Open Rules Engine (CORE); no finding represented rejection-level structural nonconformance. The generalized SDTM enabled rapid regeneration of ADaM as cohort definitions changed, including a separate cohort treated with axicabtagene ciloleucel (a chimeric antigen receptor T-cell), and supports federated analyses in which sites retain control of patient-level data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>This work demonstrates a practical, reusable pipeline for CDISC-standardized RWD in lymphoma.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/cci-26-00027","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T14:16:31Z","timestamp":1789136191000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"title":["Reusable Pipeline for Converting Real-World Lymphoma Registry Data to CDISC Standards: Implementation and Validation Using Lymphoma Epidemiology of Outcomes Consortium for Real World Evidence"],"prefix":"10.1200","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1899-6662","authenticated-orcid":true,"given":"Michael J.","family":"Kane","sequence":"first","affiliation":[{"name":"Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1153-2294","authenticated-orcid":true,"given":"Dai","family":"Chihara","sequence":"additional","affiliation":[{"name":"Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Ayers","sequence":"additional","affiliation":[{"name":"Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9524-3990","authenticated-orcid":true,"given":"Christopher R.","family":"Flowers","sequence":"additional","affiliation":[{"name":"Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2022007687"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2024012838"},{"key":"e_1_3_6_4_2","first-page":"1117","article-title":"Exploring the use of real-world evidence and complex clinical trial design by the European Pharmaceutical Industry","volume":"109","author":"Lee LJ","year":"2021","unstructured":"Lee LJ, Mannix S, Costello J, et al: Exploring the use of real-world evidence and complex clinical trial design by the European Pharmaceutical Industry. Clin Pharmacol Ther 109:1117-1127, 2021","journal-title":"Clin Pharmacol Ther"},{"key":"e_1_3_6_5_2","volume-title":"Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative","author":"Raman SR","year":"2021","unstructured":"Raman SR, O'Brien EC, Hammill BG, et al: Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative. 2021"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-25-1255"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2021.695936"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2022.05.016"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2025.104324"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2020.06.006"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-21-2639"},{"key":"e_1_3_6_12_2","first-page":"639","article-title":"The use of real-world evidence to support FDA post-approval study requirements for oncology drugs","volume":"22","author":"Bolisl S","year":"2022","unstructured":"Bolisl S, de Luserna di Ror\u00e0 AG, Tiu C, et al: The use of real-world evidence to support FDA post-approval study requirements for oncology drugs. Expert Rev Anticancer Ther 22:639-646, 2022","journal-title":"Expert Rev Anticancer Ther"},{"key":"e_1_3_6_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2024.11.014"},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.27630"},{"key":"e_1_3_6_15_2","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2023.283737"},{"key":"e_1_3_6_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(22)00033-3"},{"key":"e_1_3_6_17_2","doi-asserted-by":"publisher","DOI":"10.1177\/009286150103500323"},{"key":"e_1_3_6_18_2","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2025","unstructured":"R Core Team: R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, 2025. https:\/\/www.R-project.org\/"},{"key":"e_1_3_6_19_2","doi-asserted-by":"publisher","DOI":"10.32614\/CRAN.package.sdtm.oak"},{"key":"e_1_3_6_20_2","doi-asserted-by":"publisher","DOI":"10.32614\/CRAN.package.admiral"},{"key":"e_1_3_6_21_2","doi-asserted-by":"publisher","DOI":"10.32614\/CRAN.package.admiralonco"},{"key":"e_1_3_6_22_2","volume-title":"Cdisc-Rules-Engine","author":"CDISC","year":"2026","unstructured":"CDISC: Cdisc-Rules-Engine, 2026. https:\/\/github.com\/cdisc-org\/cdisc-rules-engine"},{"key":"e_1_3_6_23_2","first-page":"A8","article-title":"Key considerations and methods in the study of real-world evidence","volume":"122","author":"Thorlund K","year":"2020","unstructured":"Thorlund K, Dron L, Park JJH, et al: Key considerations and methods in the study of real-world evidence. J Clin Epidemiol 122:A8-A14, 2020","journal-title":"J Clin Epidemiol"},{"key":"e_1_3_6_24_2","volume-title":"FDA ODAC Votes 8-to-1 Against Applicability of Glofitamab DLBCL Data","author":"Conroy R","year":"2025","unstructured":"Conroy R: FDA ODAC Votes 8-to-1 Against Applicability of Glofitamab DLBCL Data. 2025"},{"key":"e_1_3_6_25_2","volume-title":"Oncology Real World Evidence Program","author":"U.S. Food and Drug Administration (FDA), Oncology Center of Excellence (OCE)","year":"2026","unstructured":"U.S. Food and Drug Administration (FDA), Oncology Center of Excellence (OCE): Oncology Real World Evidence Program. 2026. https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/oncology-real-world-evidence-program"}],"container-title":["JCO Clinical Cancer Informatics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/CCI-26-00027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T14:16:32Z","timestamp":1789136192000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/CCI-26-00027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":24,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1200\/CCI-26-00027"],"URL":"https:\/\/doi.org\/10.1200\/cci-26-00027","relation":{},"ISSN":["2473-4276"],"issn-type":[{"value":"2473-4276","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2026-01-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-26","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-16","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":"e2600027"}}