{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T06:19:34Z","timestamp":1790144374505,"version":"4.0.1"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T00:00:00Z","timestamp":1727308800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>While recruitment rates in inflammatory bowel disease (IBD) trials are continuously decreasing, the underlying reasons are likely multifactorial but remain poorly defined. Screen failure (SF) proportions and causes have not been extensively explored in IBD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>We assessed SF proportions and underlying SF reasons in IBD phase 2 and 3 clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed SF-related data from 17 randomized controlled phase 2 or 3 IBD trials. Twelve trials were in ulcerative colitis (UC) and 5 trials were in Crohn\u2019s disease (CD) operated by a single contract research organization, IQVIA. Differences between patient groups were tested for significance by Mann-Whitney and Fisher\u2019s tests when appropriate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We analyzed a total of 11\u2005161 patients with UC and 5752 patients with CD. The mean SF proportion was 0.43 per trial in UC. The primary reason for SFs in UC was not meeting the overall (modified) Mayo score inclusion threshold and\/or the endoscopic subscore of at least 2 (33.8% of all SF). In CD clinical trials, the mean SF proportion was at 0.53. The primary cause for SFs was not meeting the CDAI eligibility criteria (23.1% of all SFs). SF proportions were significantly higher in CD versus UC trials (P\u2005=\u2005.027). Clostridium difficile or any other intestinal infection and not meeting tuberculosis screening criteria were other major reasons for SFs both in UC and CD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>High SF proportion in IBD clinical trials, particularly for CD studies, pose obstacles to patient recruitment. While underlying causes are diverse, arbitrarily defined clinical and\/or endoscopic eligibility criteria remain the major limiting factors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izae233","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T20:24:44Z","timestamp":1726086284000},"page":"1811-1818","source":"Crossref","is-referenced-by-count":5,"title":["Screen Failures and Causes in Inflammatory Bowel Disease Randomized Controlled Trials: A Study of 16 913 Screened Patients"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7761-2879","authenticated-orcid":false,"given":"Mathieu","family":"Uzzan","sequence":"first","affiliation":[{"name":"Paris Est Cr\u00e9teil University UPEC, Assistance Publique-H\u00f4pitaux de Paris (AP-HP), Henri Mondor Hospital, Gastroenterology Department, F\u00e9d\u00e9ration Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs , Cr\u00e9teil ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgi","family":"Georgiev","sequence":"additional","affiliation":[{"name":"IQVIA, IBD Department , Sofia ,","place":["Bulgaria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Nancy University Hospital Inserm NGERE U1256, Lorraine University , Vandoeuvre-Les-Nancy ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoram","family":"Bouhnik","sequence":"additional","affiliation":[{"name":"Paris IBD Center, Groupe Hospitalier Priv\u00e9 Ambroise Par\u00e9-Hartmann , Neuilly-sur-Seine ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeraj","family":"Narula","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute , Hamilton, ON ,","place":["Canada"]},{"name":"McMaster University , Hamilton, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, Western University , London, ON ,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-3758","authenticated-orcid":false,"given":"Ryan","family":"Ungaro","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, IBD Center, Mount Sinai Hospital , New York, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3312-5139","authenticated-orcid":false,"given":"Johan","family":"Burisch","sequence":"additional","affiliation":[{"name":"Gastrounit, Medical Division, University Hospital Copenhagen\u2014Amager and Hvidovre , Hvidovre ,","place":["Denmark"]},{"name":"Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University Hospital Copenhagen\u2014Amager and Hvidovre , Hvidovre ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Kirchgesner","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, AP-HP, H\u00f4pital Saint-Antoine , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bram","family":"Verstockt","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven , Leuven ,","place":["Belgium"]},{"name":"Department of Chronic Diseases and Metabolism, KU Leuven , Leuven ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fez","family":"Hussain","sequence":"additional","affiliation":[{"name":"IQVIA, IBD Department , Sofia ,","place":["Bulgaria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2088-091X","authenticated-orcid":false,"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Medizinische Universit\u00e4t Wien Klinische Abt. 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