{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:19:34Z","timestamp":1792718374377,"version":"4.5.0"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,2,15]],"date-time":"2026-02-15T00:00:00Z","timestamp":1771113600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,15]],"date-time":"2026-02-15T00:00:00Z","timestamp":1771113600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,6]]},"abstract":"\n Investigator\u2010initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I\u2010CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6\u2009years. We describe patients and investigators' involvement in I\u2010CARE and identify predictors of early withdrawal due to patient non\u2010engagement. Patients' characteristics according to the number of electronic Patient\u2010reported outcomes (ePRO) completed during follow\u2010up were assessed. Predictors of early withdrawal due to patient non\u2010engagement were identified using logistic regression. The coding of outcomes reported by patients and corrections by investigators on patients' ePROs were assessed. Among 12,846 patients included by 502 investigators, 79.3% and 77.3% filled more than one ePRO and at least one ePRO within 6 months before the study end date, respectively. All ePROs were completed in 72.8% and 56.4% of patients during year 1 and 3, respectively. Male gender, younger age (<\u200920), being unemployed or a student, and no previous history of abdominal surgery were associated with early withdrawal. Investigators corrected 52.5% of cancer or dysplasia reported by patients compared to 10% of serious infections. Investigators added or removed a treatment sequence in 19.6% of the 6708 patients treated with biologics. These results highlight the implication of patients in research and the importance of data validation by investigators alongside the challenge and potential of collecting medical data from patients. These findings can inform similar future initiatives in other diseases. (EudraCT, Number: 2014\u2010004728\u201023;\n ClinicalTrials.gov<\/jats:ext-link>\n , Number: NCT02377258).\n <\/jats:p>","DOI":"10.1002\/cpt.70231","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T06:57:23Z","timestamp":1771225043000},"page":"1537-1546","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Building a Robust Investigator\u2010Initiated Platform: The I\u2010\n CARE<\/scp>\n Experience"],"prefix":"10.1002","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2314-9284","authenticated-orcid":false,"given":"Julien","family":"Kirchgesner","sequence":"first","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, Team FORECAST, Assistance Publique\u2010H\u00f4pitaux de Paris, H\u00f4pital Saint\u2010Antoine, Department of Gastroenterology F\u201075012 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5012-4146","authenticated-orcid":false,"given":"Laurent","family":"Beaugerie","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, Team FORECAST, Assistance Publique\u2010H\u00f4pitaux de Paris, H\u00f4pital Saint\u2010Antoine, Department of Gastroenterology F\u201075012 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4887-9459","authenticated-orcid":false,"given":"C\u00e9dric","family":"Baumann","sequence":"additional","affiliation":[{"name":"Methodology, Data Management and Statistics Unit, University Hospital of Nancy 54000 Nancy France"},{"name":"UMR 1319 INSPIIRE University of Lorraine 54000 Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4370-6708","authenticated-orcid":false,"given":"Filip","family":"Baert","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, AZ Delta Roeselare Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7738-0238","authenticated-orcid":false,"given":"Jean\u2010Fran\u00e7ois","family":"Rahier","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, CHU UCL Namur Universit\u00e9 Catholique de Louvain Yvoir Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1906-0746","authenticated-orcid":false,"given":"Daniel","family":"Bergemalm","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health, Department of Gastroenterology \u00d6rebro University \u00d6rebro Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4589-9497","authenticated-orcid":false,"given":"Fiorella","family":"Ca\u00f1ete","sequence":"additional","affiliation":[{"name":"Gastroentrology Department, Hospital Germans Trias i Pujol Badalona Catalonia Spain"},{"name":"CIBEREHD Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5748-4841","authenticated-orcid":false,"given":"B\u00e9n\u00e9dicte","family":"Caron","sequence":"additional","affiliation":[{"name":"INFINY Institute, Department of Gastroenterology, CHRU Nancy, INSERM NGERE Universit\u00e9 de Lorraine F\u201054500 Vand\u0153uvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Cossignani","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ospedale dei Castelli Ariccia Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Dias","sequence":"additional","affiliation":[{"name":"GEDII, IBD Portuguese Group Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaudia","family":"Farkas","sequence":"additional","affiliation":[{"name":"Center for Gastroenterology, Department of Internal Medicine University of Szeged Szeged Hungary"},{"name":"HCEMM\u2010USZ Translational Colorectal Research Group Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parker","family":"Girod","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, St Vincent's University Hospital & School of Medicine University College Dublin INITIATIVE, Investigator Network for IBD Research in Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Idan","family":"Goren","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel, Affiliated With Faculty of Medicine Tel Aviv University Tel Aviv Israel"},{"name":"Division of Gastroenterology State University of New York Upstate Medical University Syracuse New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Holvoet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, VITAZ Moerlandstraat 1 Sint Niklaas Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Krasz","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Dresden, Medizinische Klinik 1 Abteilung Gastroenterologie, Fetscherstr. 74 01307 Dresden Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditi","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology The Royal Wolverhampton NHS Trust UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Rimmer","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology University Hospitals Birmingham NHS Foundation Trust, Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliette","family":"Sheridan","sequence":"additional","affiliation":[{"name":"Center for Gastroenterology, Department of Internal Medicine University of Szeged Szeged Hungary"},{"name":"HCEMM\u2010USZ Translational Colorectal Research Group Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Thut","sequence":"additional","affiliation":[{"name":"Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary Hull UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7761-2879","authenticated-orcid":false,"given":"Mathieu","family":"Uzzan","sequence":"additional","affiliation":[{"name":"Paris Est Cr\u00e9teil University UPEC, Assistance Publique\u2010H\u00f4pitaux de Paris (AP\u2010HP), Henri Mondor Hospital, Gastroenterology Department F\u00e9d\u00e9ration Hospitalo\u2010Universitaire TRUE InnovaTive theRapy for immUne disordErs Cr\u00e9teil France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikos","family":"Viazis","sequence":"additional","affiliation":[{"name":"Gastroenterology Department Evangelismos General Hospital Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Weimers","sequence":"additional","affiliation":[{"name":"Department of\u00a0Gastroenterology North Zealand University Hospital Frederikssund Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edyta","family":"Zag\u00f3rowicz","sequence":"additional","affiliation":[{"name":"Department of Oncological Gastroenterology, The Maria Sklodowska\u2010Curie National Research Institute of Oncology, Department of Gastroenterology, Hepatology and Clinical Oncology Centre of Postgraduate\u00a0Medical Education Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4249-194X","authenticated-orcid":false,"given":"Anne","family":"Buisson","sequence":"additional","affiliation":[{"name":"Association Fran\u00e7ois\u2010Aupetit, AFA Crohn RCH Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6197-9126","authenticated-orcid":false,"given":"Luisa","family":"Avedano","sequence":"additional","affiliation":[{"name":"European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA) Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helene","family":"Rousseau","sequence":"additional","affiliation":[{"name":"Methodology, Data Management and Statistics Unit, University Hospital of Nancy 54000 Nancy France"},{"name":"UMR 1319 INSPIIRE University of Lorraine 54000 Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-6618","authenticated-orcid":false,"given":"Laurent","family":"Peyrin\u2010Biroulet","sequence":"additional","affiliation":[{"name":"INFINY Institute, Department of Gastroenterology, CHRU Nancy, INSERM NGERE Universit\u00e9 de Lorraine F\u201054500 Vand\u0153uvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3670-6545","authenticated-orcid":false,"given":"Shaji","family":"Sebastian","sequence":"additional","affiliation":[{"name":"IBD Unit, Hull University Teaching Hospitals Hull UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"I\u2010CARE Collaborator Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,15]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.01.055"},{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2015.150"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13835"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.07.013"},{"key":"e_1_2_12_5_1","article-title":"Assessing electronic health records and medical claims data to support regulatory decision\u2010making for drug and biological products \u2010 guidance for industry","author":"FDA Real\u2010World 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Accessed 1 January 2024."},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1909094"}],"container-title":["Clinical Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70231","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70231","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70231","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T03:31:38Z","timestamp":1778297498000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70231"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,15]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1002\/cpt.70231"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70231","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,15]]},"assertion":[{"value":"2025-09-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}