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Med."],"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>Clinical practice is currently guided by studies that average over patient outcomes. This may not be the best approach, as different patients may have different treatment responses. Here we extend a method for simulating clinical trials to identify optimal treatments for each patient, and we illustrate this approach in the context of Crohn\u2019s disease. Using the data from 15 randomized trials (<jats:italic>N<\/jats:italic>\u2009=\u20095703), we used statistical hypothesis testing to identify seven subgroups with distinct responses to three different drug classes. The largest subgroup consisted of patients with equivocal responses to all drug classes, whereas the second largest showed superiority with anti-TNFs. We also identified a subgroup of women over 50 with superior responses to anti-IL-12\/23s. Interestingly, this group appeared under-represented in the trials (2%) compared to patients at the University of California (25%). Overall, these results underscore the importance of studying personalized medicine, demonstrate the value of clinical trial data, and provide a roadmap for applying this method broadly across diseases. These results also highlight the importance of diverse and representative recruitment into clinical trials.<\/jats:p>","DOI":"10.1038\/s41746-025-01627-w","type":"journal-article","created":{"date-parts":[[2025,5,31]],"date-time":"2025-05-31T11:20:16Z","timestamp":1748690416000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["From trial data to personalized medicine: a validated framework with an application to Crohn\u2019s disease"],"prefix":"10.1038","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1789-3004","authenticated-orcid":false,"given":"Vivek A.","family":"Rudrapatna","sequence":"first","affiliation":[]},{"given":"Vignesh G.","family":"Ravindranath","sequence":"additional","affiliation":[]},{"given":"Douglas V.","family":"Arneson","sequence":"additional","affiliation":[]},{"given":"Arman","family":"Mosenia","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7433-2740","authenticated-orcid":false,"given":"Atul J.","family":"Butte","sequence":"additional","affiliation":[]},{"given":"Shan","family":"Wang","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2025,5,31]]},"reference":[{"key":"1627_CR1","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.1016\/S2468-1253(21)00312-5","volume":"6","author":"S Singh","year":"2021","unstructured":"Singh, S. et al. 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VGR is currently employed by Epic Systems Corporation. DVA is currently an employee at Bristol Myers Squibb. AM has no potential conflicts to disclose. AJB is a co-founder and consultant to Personalis and NuMedii; consultant to Mango Tree Corporation, and in the recent past, Samsung, 10x Genomics, Helix, Pathway Genomics, and Verinata (Illumina); has served on paid advisory panels or boards for Geisinger Health, Regenstrief Institute, Gerson Lehman Group, AlphaSights, Covance, Novartis, Genentech, and Merck, and Roche; is a shareholder in Personalis and NuMedii; is a minor shareholder in Apple, Meta (Facebook), Alphabet (Google), Microsoft, Amazon, Snap, 10x Genomics, Illumina, Regeneron, Sanofi, Pfizer, Royalty Pharma, Moderna, Sutro, Doximity, BioNtech, Invitae, Pacific Biosciences, Editas Medicine, Nuna Health, Assay Depot, and Vet24seven, and several other non-health related companies and mutual funds; and has received honoraria and travel reimbursement for invited talks from Johnson and Johnson, Roche, Genentech, Pfizer, Merck, Lilly, Takeda, Varian, Mars, Siemens, Optum, Abbott, Celgene, AstraZeneca, AbbVie, Westat, and many academic institutions, medical or disease specific foundations and associations, and health systems. Atul Butte receives royalty payments through Stanford University, for several patents and other disclosures licensed to NuMedii and Personalis. Atul Butte\u2019s research has been funded by NIH, Peraton (as the prime on an NIH contract), Genentech, Johnson and Johnson, FDA, Robert Wood Johnson Foundation, Leon Lowenstein Foundation, Intervalien Foundation, Priscilla Chan and Mark Zuckerberg, the Barbara and Gerson Bakar Foundation, and in the recent past, the March of Dimes, Juvenile Diabetes Research Foundation, California Governor\u2019s Office of Planning and Research, California Institute for Regenerative Medicine, L\u2019Oreal, and Progenity. SW has no potential conflicts to disclose. The authors declare that no actual competing interests exist.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"327"}}