Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab
Yu, Hui Jing
Huang, Christopher S.
Mishkin, Daniel S.
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CitationAhmad, Harris, Tyler M. Berzin, Hui Jing Yu, Christopher S. Huang, and Daniel S. Mishkin. 2014. “Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab.” Gastroenterology Report 2 (3): 201-206. doi:10.1093/gastro/gou033. http://dx.doi.org/10.1093/gastro/gou033.
AbstractClinical 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.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:12785984
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