Abstract:
:Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.
journal_name
Gutjournal_title
Gutauthors
Gottlieb K,Daperno M,Usiskin K,Sands BE,Ahmad H,Howden CW,Karnes W,Oh YS,Modesto I,Marano C,Stidham RW,Reinisch Wdoi
10.1136/gutjnl-2020-320690subject
Has Abstractpub_date
2021-02-01 00:00:00pages
418-426issue
2eissn
0017-5749issn
1468-3288pii
gutjnl-2020-320690journal_volume
70pub_type
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