title: Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab.
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.
authors.affiliation: Medical Affairs, BioClinica Inc. Newtown, Pennsylvania, USA; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA; Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA; Division of Gastroenterology, Granite Medical Group, Boston Medical Center, Boston, MA, USA harris.ahmad@bioclinica.com.
authors.forename: Harris
authors.initials: H
authors.lastname: Ahmad
authors.affiliation: Medical Affairs, BioClinica Inc. Newtown, Pennsylvania, USA; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA; Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA; Division of Gastroenterology, Granite Medical Group, Boston Medical Center, Boston, MA, USA.
authors.forename: Tyler M
authors.initials: TM
authors.lastname: Berzin
authors.affiliation: Medical Affairs, BioClinica Inc. Newtown, Pennsylvania, USA; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA; Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA; Division of Gastroenterology, Granite Medical Group, Boston Medical Center, Boston, MA, USA.
authors.forename: Hui Jing
authors.initials: HJ
authors.lastname: Yu
authors.affiliation: Medical Affairs, BioClinica Inc. Newtown, Pennsylvania, USA; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA; Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA; Division of Gastroenterology, Granite Medical Group, Boston Medical Center, Boston, MA, USA.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Huang
authors.affiliation: Medical Affairs, BioClinica Inc. Newtown, Pennsylvania, USA; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA; Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA; Division of Gastroenterology, Granite Medical Group, Boston Medical Center, Boston, MA, USA.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Mishkin
keywords: clinical trials; imaging core laboratories; inflammatory bowel disease