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Review
. 2014 Aug;2(3):201-6.
doi: 10.1093/gastro/gou033. Epub 2014 Jul 3.

Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab

Harris Ahmad  1 , Tyler M Berzin  2 , Hui Jing Yu  2 , Christopher S Huang  2 , Daniel S Mishkin  2
Affiliations
Review

Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab

Harris Ahmad et al. Gastroenterol Rep (Oxf). 2014 Aug.

Abstract

Clinical trials in inflammatory bowel disease (IBD) are evolving at a rapid pace by employing central reading for endoscopic mucosal assessment in a field that was, historically, largely based on assessments by local physicians. This transition from local to central reading carries with it numerous technical, operational, and scientific challenges, many of which can be resolved by imaging core laboratories (ICLs), a concept that has a longer history in clinical trials in a number of diseases outside the realm of gastroenterology. For IBD trials, ICLs have the dual goals of providing objective, consistent assessments of endoscopic findings using central-reading paradigms whilst providing important expertise with regard to operational issues and regulatory expectations. This review focuses on current approaches to using ICLs for central endoscopic reading in IBD trials.

Keywords: clinical trials; imaging core laboratories; inflammatory bowel disease.

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