title: Central Reading of Endoscopy Endpoints in Inflammatory Bowel Disease Trials.
abstract: BACKGROUND
  Central reading of endoscopy (CROE) is crucial in determining who qualifies for a trial but also has a role, independent of the selected scoring system, in decreasing measurement noise that can obscure separation between placebo and active drug. Benefits of CROE may not be independent of the method chosen, and controversy exists about the ideal approach.
  
  
  METHODS
  Literature review and concept development.
  
  
  RESULTS
  Components to be considered in the reading algorithm are blinding, number of central readers, independent voting versus consensus panel, video recordings versus still images, and involvement of the site reader. Key concepts considered are endpoints, bias, power, and sample size derived from the Food and Drug Administration and European Medicines Agency guidelines, as well as the technological requirements and recruitment, qualification, and revalidation of central readers as applied to CROE.
  
  
  CONCLUSIONS
  Recording and CROE should be standardized, and an imaging charter developed with research on the different components and its overall impact.
authors.affiliation: *Gastroenterology Center of Excellence, Quintiles, Durham, North Carolina; †Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, United Kingdom; ‡Robarts Research Institute, Western University, London, ON, Canada; §Division of Gastroenterology, University of California San Diego, San Diego, California; and ||Division of Translational Research in Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.
authors.forename: Klaus
authors.initials: K
authors.lastname: Gottlieb
authors.forename: Simon
authors.initials: S
authors.lastname: Travis
authors.forename: Brian
authors.initials: B
authors.lastname: Feagan
authors.forename: Fez
authors.initials: F
authors.lastname: Hussain
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D016099:Endoscopy, Gastrointestinal / Q000592:standards*; D023381:Endpoint Determination / Q000379:methods*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D015212:Inflammatory Bowel Diseases / Q000473:pathology*; D015588:Observer Variation; D017410:Practice Guidelines as Topic