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A prerequisite for meaningful RCT emulation insights is the identification and use of RWD with sufficient fitness to satisfy RCT\u2010specific data elements. We conducted a systematic, multi\u2010stage feasibility assessment of six commercially available US electronic health record\u2010based RWD sources across 23 candidate oncology RCTs. Each potential RCT\u2010RWD combination was first screened for availability of the RCT indication, outcomes, and sample size \u2265\u20091.5\u2010times enrollment for each trial arm. Combinations passing this screen underwent more detailed evaluation of RCT design elements including eligibility criteria, outcomes, and potential confounders. Each data element was rated with respect to availability, missingness, and validity. Final feasibility determination was informed by ratings of essential element capture and refined sample size estimates. Of 54 candidate RCT\u2010RWD combinations assessed, nine advanced to detailed feasibility assessment and three were selected for emulation protocol development.\n                    <jats:italic>Fit\u2010for\u2010emulation<\/jats:italic>\n                    constraints included complex eligibility criteria, biomarker requirements, performance status requirements, and outcome ascertainment. These findings highlight the importance of systematic feasibility evaluation before conducting emulations and may inform data selection for future RWD studies in oncology. Data fitness for oncology RCT emulation could be improved by linking high\u2010quality, oncology\u2010specific RWD sources to broader EHR and claims data sources or through customized data abstraction.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70310","type":"journal-article","created":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T11:11:58Z","timestamp":1780571518000},"page":"440-451","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Systematic Evaluation of Data and Trial Fitness for Oncology Trial Emulation: Empirical Findings from the CARE Initiative"],"prefix":"10.1002","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6828-8237","authenticated-orcid":false,"given":"Natalie","family":"Levy","sequence":"first","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2099-6760","authenticated-orcid":false,"given":"Paige","family":"Sheridan","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3503-8178","authenticated-orcid":false,"given":"Ulka","family":"Campbell","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8697-1737","authenticated-orcid":false,"given":"David","family":"Lenis","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9958-5333","authenticated-orcid":false,"given":"Inish","family":"O'Doherty","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8866-2911","authenticated-orcid":false,"given":"Adina","family":"Estrin","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3643-433X","authenticated-orcid":false,"given":"Nileesa","family":"Gautam","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1656-8370","authenticated-orcid":false,"given":"Monica","family":"Iyer","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"McDonald","sequence":"additional","affiliation":[{"name":"Aetion, Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Belli","sequence":"additional","affiliation":[{"name":"COTA Healthcare  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7973-3607","authenticated-orcid":false,"given":"Gillis","family":"Carrigan","sequence":"additional","affiliation":[{"name":"Center for Observational Research Amgen  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8161-1986","authenticated-orcid":false,"given":"K. 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National Institute for Health and Care Excellence <https:\/\/www.nice.org.uk\/corporate\/ecd9\/chapter\/methods\u2010for\u2010real\u2010world\u2010studies\u2010of\u2010comparative\u2010effects> (2022). Accessed July 31 2024."},{"key":"e_1_2_8_9_1","unstructured":"Center for Drug Evaluation and Research Center for Biologics Evaluation Oncology Center of Excellence.Considerations for the use of real\u2010world data and real\u2010world evidence to support regulatory decision\u2010making for drug and biological products. U.S. Food and Drug Administration <https:\/\/www.fda.gov\/media\/171667\/download> (2023) Accessed December 21 2023."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200006223422507"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32383"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41391-021-00487-1"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2800"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.72.6414"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1633"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.4221"},{"key":"e_1_2_8_17_1","unstructured":"Center for Drug Evaluation and Research Center for Biologics Evaluation and Research.Real\u2010world evidence: considerations regarding non\u2010interventional studies for drug and biological products. U.S. Food and Drug Administration <https:\/\/www.fda.gov\/media\/152503\/download> (2024). Accessed July 3 2024."},{"key":"e_1_2_8_18_1","unstructured":"European Medicines Agency Data Analytics and Methods Task Force.Data quality framework for EU medicines regulation<https:\/\/www.ema.europa.eu\/en\/documents\/regulatory\u2010procedural\u2010guideline\/data\u2010quality\u2010framework\u2010eu\u2010medicines\u2010regulation_en.pdf> (2022). Accessed February 10 2025."},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5010"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2466"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2883"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5862"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5818"},{"key":"e_1_2_8_24_1","unstructured":"Desai K. Chandwani S. Ru B. Reynolds M.W. 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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use <https:\/\/database.ich.org\/sites\/default\/files\/ICH_M14_Step3_DraftGuideline_2024_0521.pdf>. (2024). Accessed July 9 2024."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70310","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70310","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70310","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T03:19:01Z","timestamp":1783912741000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70310"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,4]]},"references-count":33,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1002\/cpt.70310"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70310","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,4]]},"assertion":[{"value":"2025-09-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-01","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-04","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}