{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T13:56:32Z","timestamp":1783691792407,"version":"3.55.0"},"reference-count":51,"publisher":"Elsevier BV","issue":"1","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.fr","clinicalkey.jp","clinicalkey.es","clinicalkey.com.au","clinicalkey.com","cghjournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinical Gastroenterology and Hepatology"],"published-print":{"date-parts":[[2025,1]]},"DOI":"10.1016\/j.cgh.2024.08.028","type":"journal-article","created":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T06:20:09Z","timestamp":1726726809000},"page":"14-23","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":6,"title":["Personalized (N-of-1) Clinical Trials for Inflammatory Bowel Disease: Opportunities and Challenges"],"prefix":"10.1016","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6657-2763","authenticated-orcid":false,"given":"Sailish","family":"Honap","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangyong","family":"Zou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cgh.2024.08.028_bib1","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1016\/S0140-6736(23)00966-2","article-title":"Ulcerative colitis","volume":"402","author":"Berre","year":"2023","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2024.08.028_bib2","doi-asserted-by":"crossref","first-page":"1177","DOI":"10.1016\/S0140-6736(23)02586-2","article-title":"Crohn\u2019s disease","volume":"403","author":"Dolinger","year":"2024","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2024.08.028_bib3","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1038\/s41575-021-00555-w","article-title":"Precision medicine in IBD: genes, drugs, bugs and omics","volume":"19","author":"Mao","year":"2022","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2024.08.028_bib4","doi-asserted-by":"crossref","first-page":"415","DOI":"10.1016\/S2468-1253(24)00034-7","article-title":"A\u00a0biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn\u2019s disease (PROFILE): a multicentre, open-label randomised controlled trial","volume":"9","author":"Noor","year":"2024","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2024.08.028_bib5","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1111\/j.0887-378X.2004.00327.x","article-title":"Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages","volume":"82","author":"Kravitz","year":"2004","journal-title":"Milbank Q"},{"issue":"Suppl 1","key":"10.1016\/j.cgh.2024.08.028_bib6","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1016\/j.amjmed.2007.02.002","article-title":"Heterogeneity of treatment effects: implications for guidelines, payment, and quality assessment","volume":"120","author":"Greenfield","year":"2007","journal-title":"Am J Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib7","doi-asserted-by":"crossref","first-page":"1066","DOI":"10.1093\/ecco-jcc\/jjad020","article-title":"Declining enrolment and other challenges in IBD clinical trials: causes and potential solutions","volume":"17","author":"Uzzan","year":"2023","journal-title":"J\u00a0Crohns Colitis"},{"key":"10.1016\/j.cgh.2024.08.028_bib8","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1038\/s41573-024-00953-0","article-title":"Navigating the complexities of drug development for inflammatory bowel disease","volume":"23","author":"Honap","year":"2024","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/j.cgh.2024.08.028_bib9","doi-asserted-by":"crossref","first-page":"400","DOI":"10.1053\/j.gastro.2021.03.065","article-title":"Challenges and opportunities in IBD clinical trial design","volume":"161","author":"Dubinsky","year":"2021","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2024.08.028_bib10","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1056\/NEJM198604033141406","article-title":"Determining optimal therapy: randomized trials in individual patients","volume":"314","author":"Guyatt","year":"1986","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib11","doi-asserted-by":"crossref","first-page":"h1793","DOI":"10.1136\/bmj.h1793","article-title":"CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration","volume":"350","author":"Shamseer","year":"2015","journal-title":"BMJ"},{"key":"10.1016\/j.cgh.2024.08.028_bib12","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1016\/S0366-0869(50)80004-7","article-title":"Streptomycin in the treatment of pulmonary tuberculosis","volume":"44","author":"Weitzman","year":"1950","journal-title":"Br J Tuberc Dis Chest"},{"key":"10.1016\/j.cgh.2024.08.028_bib13","first-page":"163","article-title":"The self-controlled and self-recorded clinical trial for low-grade morbidity","volume":"7","author":"Hogben","year":"1953","journal-title":"Br J Prev Soc Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib14","doi-asserted-by":"crossref","first-page":"761","DOI":"10.1097\/MLR.0b013e318215d90d","article-title":"N-of-1 trials in the medical literature: a systematic review","volume":"49","author":"Gabler","year":"2011","journal-title":"Med Care"},{"key":"10.1016\/j.cgh.2024.08.028_bib15","series-title":"The Essential Guide to N-of-1 Trials in Health [Internet]","first-page":"9","article-title":"What are N-of-1 Trials?","author":"Nikles","year":"2015"},{"key":"10.1016\/j.cgh.2024.08.028_bib16","author":"Cheung"},{"key":"10.1016\/j.cgh.2024.08.028_bib17","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1002\/sim.4780030107","article-title":"Clinical trials designed to evaluate therapeutic preferences","volume":"3","author":"Baskerville","year":"1984","journal-title":"Stat Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib18","doi-asserted-by":"crossref","first-page":"1882","DOI":"10.1093\/ecco-jcc\/jjad090","article-title":"Patient and public involvement in research: lessons for inflammatory bowel disease","volume":"17","author":"Honap","year":"2023","journal-title":"J\u00a0Crohns Colitis"},{"key":"10.1016\/j.cgh.2024.08.028_bib19","doi-asserted-by":"crossref","first-page":"372","DOI":"10.1177\/0962280217726801","article-title":"Sample size considerations for n-of-1 trials","volume":"28","author":"Senn","year":"2019","journal-title":"Stat Methods Med Res"},{"key":"10.1016\/j.cgh.2024.08.028_bib20","series-title":"The essential guide to N-of-1 trials in health","first-page":"135","article-title":"Statistical analysis of N-of-1 trials","author":"Mengersen","year":"2015"},{"key":"10.1016\/j.cgh.2024.08.028_bib21","first-page":"497","article-title":"A\u00a0clinician\u2019s guide for conducting randomized trials in individual patients","volume":"139","author":"Guyatt","year":"1988","journal-title":"CMAJ"},{"key":"10.1016\/j.cgh.2024.08.028_bib22","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0167167","article-title":"Understanding Variation in Sets of N-of-1 Trials","volume":"11","author":"Araujo","year":"2016","journal-title":"PLoS One"},{"key":"10.1016\/j.cgh.2024.08.028_bib23","series-title":"Effective Health Care Program","year":"2019"},{"key":"10.1016\/j.cgh.2024.08.028_bib24","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1016\/S0895-4356(96)00429-5","article-title":"Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment","volume":"50","author":"Zucker","year":"1997","journal-title":"J\u00a0Clin Epidemiol"},{"key":"10.1016\/j.cgh.2024.08.028_bib25","doi-asserted-by":"crossref","first-page":"1312","DOI":"10.1016\/j.jclinepi.2010.04.020","article-title":"Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations","volume":"63","author":"Zucker","year":"2010","journal-title":"J\u00a0Clin Epidemiol"},{"key":"10.1016\/j.cgh.2024.08.028_bib26","doi-asserted-by":"crossref","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"SPIRIT 2013 Statement: defining standard protocol items for clinical trials","volume":"158","author":"Chan","year":"2013","journal-title":"Ann Intern Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib27","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1186\/1741-7015-8-18","article-title":"CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials","volume":"8","author":"Schulz","year":"2010","journal-title":"BMC Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib28","article-title":"SPIRIT extension and elaboration for N-of-1 trials: SPENT 2019 checklist","volume":"368","author":"Porcino","year":"2020","journal-title":"BMJ"},{"key":"10.1016\/j.cgh.2024.08.028_bib29","doi-asserted-by":"crossref","first-page":"h1738","DOI":"10.1136\/bmj.h1738","article-title":"CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement","volume":"350","author":"Vohra","year":"2015","journal-title":"BMJ"},{"key":"10.1016\/j.cgh.2024.08.028_bib30","author":"Howick"},{"key":"10.1016\/j.cgh.2024.08.028_bib31","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1093\/ecco-jcc\/jjaa161","article-title":"The medical management of paediatric Crohn\u2019s disease: an ECCO-ESPGHAN Guideline Update","volume":"15","author":"van Rheenen","year":"2021","journal-title":"J\u00a0Crohns Colitis"},{"key":"10.1016\/j.cgh.2024.08.028_bib32","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1093\/ecco-jcc\/jjab140","article-title":"Impact of drug approval pathways for paediatric inflammatory bowel disease","volume":"16","author":"Crowley","year":"2022","journal-title":"J\u00a0Crohns Colitis"},{"key":"10.1016\/j.cgh.2024.08.028_bib33","doi-asserted-by":"crossref","first-page":"820","DOI":"10.1093\/ibd\/izz259","article-title":"Very early onset inflammatory bowel disease: a clinical approach with a focus on the role of genetics and underlying immune deficiencies","volume":"26","author":"Ouahed","year":"2020","journal-title":"Inflamm Bowel Dis"},{"key":"10.1016\/j.cgh.2024.08.028_bib34","doi-asserted-by":"crossref","first-page":"726","DOI":"10.1016\/S0140-6736(86)91112-8","article-title":"Single-patient randomised clinical trial. Use in determining optimum treatment for patient with inflammation of Kock continent ileostomy reservoir","volume":"1","author":"McLeod","year":"1986","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2024.08.028_bib35","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1007\/BF01536795","article-title":"Testing nicotine gum for ulcerative colitis patients. Experience with single-patient trials","volume":"35","author":"Lashner","year":"1990","journal-title":"Dig Dis Sci"},{"key":"10.1016\/j.cgh.2024.08.028_bib36","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1056\/NEJM199403243301202","article-title":"Transdermal nicotine for active ulcerative colitis","volume":"330","author":"Pullan","year":"1994","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib37","doi-asserted-by":"crossref","first-page":"364","DOI":"10.7326\/0003-4819-126-5-199703010-00004","article-title":"Transdermal nicotine for mildly to moderately active ulcerative colitis. A randomized, double-blind, placebo-controlled trial","volume":"126","author":"Sandborn","year":"1997","journal-title":"Ann Intern Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib38","doi-asserted-by":"crossref","first-page":"988","DOI":"10.1056\/NEJM199504133321503","article-title":"Transdermal nicotine as maintenance therapy for ulcerative colitis","volume":"332","author":"Thomas","year":"1995","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib39","doi-asserted-by":"crossref","first-page":"902","DOI":"10.14309\/ajg.0000000000001800","article-title":"Personalized research on diet in ulcerative colitis and Crohn\u2019s disease: a series of N-of-1 diet trials","volume":"117","author":"Kaplan","year":"2022","journal-title":"Am J Gastroenterol"},{"key":"10.1016\/j.cgh.2024.08.028_bib40","doi-asserted-by":"crossref","first-page":"161","DOI":"10.2217\/pme.11.7","article-title":"The N-of-1 clinical trial: the ultimate strategy for individualizing medicine?","volume":"8","author":"Lillie","year":"2011","journal-title":"Per Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib41","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/j.jclinepi.2016.03.023","article-title":"N-of-1 trials are a tapestry of heterogeneity","volume":"76","author":"Punja","year":"2016","journal-title":"J\u00a0Clin Epidemiol"},{"key":"10.1016\/j.cgh.2024.08.028_bib42","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1186\/s13063-024-08100-1","article-title":"A\u00a0methodological review of randomised N-of-1 trials","volume":"25","author":"Hawksworth","year":"2024","journal-title":"Trials"},{"key":"10.1016\/j.cgh.2024.08.028_bib43","article-title":"Statin treatment and muscle symptoms: series of randomised, placebo controlled N-of-1 trials","volume":"372","author":"Herrett","year":"2021","journal-title":"BMJ"},{"key":"10.1016\/j.cgh.2024.08.028_bib44","doi-asserted-by":"crossref","first-page":"2182","DOI":"10.1056\/NEJMc2031173","article-title":"N-of-1 trial of a statin, placebo, or no treatment to assess side effects","volume":"383","author":"Wood","year":"2020","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.cgh.2024.08.028_bib45","series-title":"FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases","year":"2021"},{"key":"10.1016\/j.cgh.2024.08.028_bib47","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1111\/j.1468-0009.2008.00533.x","article-title":"What ever happened to N-of-1 trials? Insiders\u2019 perspectives and a look to the future","volume":"86","author":"Kravitz","year":"2008","journal-title":"Milbank Q"},{"key":"10.1016\/j.cgh.2024.08.028_bib48","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1016\/j.cct.2009.04.001","article-title":"Marketing therapeutic precision: potential facilitators and barriers to adoption of n-of-1 trials","volume":"30","author":"Kravitz","year":"2009","journal-title":"Contemp Clin Trials"},{"key":"10.1016\/j.cgh.2024.08.028_bib49","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1016\/j.jclinepi.2010.05.009","article-title":"Aggregating single patient (n-of-1) trials in populations where recruitment and retention was difficult: the case of palliative care","volume":"64","author":"Nikles","year":"2011","journal-title":"J\u00a0Clin Epidemiol"},{"key":"10.1016\/j.cgh.2024.08.028_bib50","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1016\/j.jclinepi.2010.05.006","article-title":"N-of-1 clinical trials should be incorporated into clinical practice","volume":"63","author":"Berlin","year":"2010","journal-title":"J\u00a0Clin Epidemiol"},{"key":"10.1016\/j.cgh.2024.08.028_bib51","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/s41398-023-02562-8","article-title":"Evidence and reporting standards in N-of-1 medical studies: a systematic review","volume":"13","author":"Natesan Batley","year":"2023","journal-title":"Transl Psychiatry"},{"key":"10.1016\/j.cgh.2024.08.028_bib52","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1002\/cpt.2425","article-title":"A\u00a0useful and sustainable role for N-of-1 trials in the healthcare ecosystem","volume":"112","author":"Selker","year":"2022","journal-title":"Clin Pharmacol Ther"}],"container-title":["Clinical Gastroenterology and Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542356524008292?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542356524008292?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,12,20]],"date-time":"2024-12-20T21:06:50Z","timestamp":1734728810000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1542356524008292"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":51,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["S1542356524008292"],"URL":"https:\/\/doi.org\/10.1016\/j.cgh.2024.08.028","relation":{},"ISSN":["1542-3565"],"issn-type":[{"value":"1542-3565","type":"print"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Personalized (N-of-1) Clinical Trials for Inflammatory Bowel Disease: Opportunities and Challenges","name":"articletitle","label":"Article Title"},{"value":"Clinical Gastroenterology and Hepatology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cgh.2024.08.028","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 by the AGA Institute","name":"copyright","label":"Copyright"}]}}