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Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
- Source :
- Gut
- Publication Year :
- 2020
- Publisher :
- BMJ, 2020.
-
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.
- Subjects :
- medicine.medical_specialty
ENDOSCOPY
Endpoint Determination
media_common.quotation_subject
Colonoscopy
Statistical power
Crohn Disease
Reading (process)
Recent Advances in Clinical Practice
medicine
Humans
Medical physics
Quality (business)
Duration (project management)
media_common
Observer Variation
Clinical Trials as Topic
medicine.diagnostic_test
Remission Induction
INFLAMMATORY BOWEL DISEASE
Gastroenterology
Retraining
Inflammatory Bowel Diseases
Clinical trial
Workflow
Psychology
Algorithms
CLINICAL TRIALS
Forecasting
Subjects
Details
- ISSN :
- 14683288 and 00175749
- Database :
- OpenAIRE
- Journal :
- Gut
- Accession number :
- edsair.doi.dedup.....bfa5c66127f118fbd6ea69f6fd70e92f
- Full Text :
- https://doi.org/10.1136/gutjnl-2020-320690