Screen Failures and Causes in Inflammatory Bowel Disease Randomized Controlled Trials: A Study of 16 913 Screened Patients.
Introduction 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. Aim We assessed SF proportion...
| Publicado en: | Inflammatory Bowel Diseases Vol. 31; no. 7; pp. 1811 - 1819 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Jul2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=187102431&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 187102431 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10780998 N0V jtl: Inflammatory Bowel Diseases issn: 10780998 maglogo: N pubinfo: dt: Jul2025 vid: 31 iid: 7 pid: 622 pub: Oxford University Press / USA artinfo: ui: 187102431 187102431 187102431 10.1093/ibd/izae233 187102431 ppf: 1811 ppct: 8 formats: tig: atl: Screen Failures and Causes in Inflammatory Bowel Disease Randomized Controlled Trials: A Study of 16 913 Screened Patients. aug: au: Uzzan, Mathieu Georgiev, Georgi Peyrin-Biroulet, Laurent Bouhnik, Yoram Narula, Neeraj Jairath, Vipul Ungaro, Ryan Burisch, Johan Kirchgesner, Julien Verstockt, Bram Hussain, Fez Reinisch, Walter affil: Paris Est Créteil University UPEC, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Gastroenterology Department, Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Créteil, France sug: subj: Research Subject Recruitment Evaluation Randomized Controlled Trials Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease Human Clinical Trials Mann-Whitney U Test Fisher's Exact Test Scales Endoscopy Descriptive Statistics Clostridioides Difficile Tuberculosis Eligibility Determination ab: Introduction 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. Aim We assessed SF proportions and underlying SF reasons in IBD phase 2 and 3 clinical trials. Methods 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's disease (CD) operated by a single contract research organization, IQVIA. Differences between patient groups were tested for significance by Mann-Whitney and Fisher's tests when appropriate. Results We analyzed a total of 11 161 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 = .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. Conclusion 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. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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