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Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments

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...

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Autores principales: Gottlieb, Klaus, Daperno, Marco, Usiskin, Keith, Sands, Bruce E, Ahmad, Harris, Howden, Colin W, Karnes, William, Oh, Young S, Modesto, Irene, Marano, Colleen, Stidham, Ryan William, Reinisch, Walter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815632/
https://www.ncbi.nlm.nih.gov/pubmed/32699100
http://dx.doi.org/10.1136/gutjnl-2020-320690
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author Gottlieb, Klaus
Daperno, Marco
Usiskin, Keith
Sands, Bruce E
Ahmad, Harris
Howden, Colin W
Karnes, William
Oh, Young S
Modesto, Irene
Marano, Colleen
Stidham, Ryan William
Reinisch, Walter
author_facet Gottlieb, Klaus
Daperno, Marco
Usiskin, Keith
Sands, Bruce E
Ahmad, Harris
Howden, Colin W
Karnes, William
Oh, Young S
Modesto, Irene
Marano, Colleen
Stidham, Ryan William
Reinisch, Walter
author_sort Gottlieb, Klaus
collection PubMed
description 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.
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spelling pubmed-78156322021-01-25 Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments Gottlieb, Klaus Daperno, Marco Usiskin, Keith Sands, Bruce E Ahmad, Harris Howden, Colin W Karnes, William Oh, Young S Modesto, Irene Marano, Colleen Stidham, Ryan William Reinisch, Walter Gut Recent Advances in Clinical Practice 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. BMJ Publishing Group 2021-02 2020-07-22 /pmc/articles/PMC7815632/ /pubmed/32699100 http://dx.doi.org/10.1136/gutjnl-2020-320690 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Recent Advances in Clinical Practice
Gottlieb, Klaus
Daperno, Marco
Usiskin, Keith
Sands, Bruce E
Ahmad, Harris
Howden, Colin W
Karnes, William
Oh, Young S
Modesto, Irene
Marano, Colleen
Stidham, Ryan William
Reinisch, Walter
Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title_full Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title_fullStr Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title_full_unstemmed Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title_short Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
title_sort endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
topic Recent Advances in Clinical Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815632/
https://www.ncbi.nlm.nih.gov/pubmed/32699100
http://dx.doi.org/10.1136/gutjnl-2020-320690
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