The use of digital pathology and image analysis in clinical trials
The use of digital pathology and image analysis in clinical trials
Digital pathology and image analysis potentially provide greater accuracy, reproducibility and standardisation of pathology-based trial entry criteria and endpoints, alongside extracting new insights from both existing and novel features. Image analysis has great potential to identify, extract and quantify features in greater detail in comparison to pathologist assessment, which may produce improved prediction models or perform tasks beyond manual capability. In this article, we provide an overview of the utility of such technologies in clinical trials and provide a discussion of the potential applications, current challenges, limitations and remaining unanswered questions that require addressing prior to routine adoption in such studies. We reiterate the value of central review of pathology in clinical trials, and discuss inherent logistical, cost and performance advantages of using a digital approach. The current and emerging regulatory landscape is outlined. The role of digital platforms and remote learning to improve the training and performance of clinical trial pathologists is discussed. The impact of image analysis on quantitative tissue morphometrics in key areas such as standardisation of immunohistochemical stain interpretation, assessment of tumour cellularity prior to molecular analytical applications and the assessment of novel histological features is described. The standardisation of digital image production, establishment of criteria for digital pathology use in pre-clinical and clinical studies, establishment of performance criteria for image analysis algorithms and liaison with regulatory bodies to facilitate incorporation of image analysis applications into clinical practice are key issues to be addressed to improve digital pathology incorporation into clinical trials.
computerised image analysis, digital image analysis, digital microscopy
Pell, Robert
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Oien, Karin
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Robinson, Max
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Pitman, Helen
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Rajpoot, Nasir
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Rittscher, Jens
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Snead, David
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Verrill, Clare
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Thomas, Gareth J.
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On behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
Pell, Robert
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Oien, Karin
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Robinson, Max
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Pitman, Helen
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Rajpoot, Nasir
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Rittscher, Jens
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Snead, David
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Verrill, Clare
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Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106
Pell, Robert, Oien, Karin, Robinson, Max, Pitman, Helen, Rajpoot, Nasir, Rittscher, Jens, Snead, David and Verrill, Clare
,
On behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
(2019)
The use of digital pathology and image analysis in clinical trials.
Journal of Pathology: Clinical Research.
(doi:10.1002/cjp2.127).
Abstract
Digital pathology and image analysis potentially provide greater accuracy, reproducibility and standardisation of pathology-based trial entry criteria and endpoints, alongside extracting new insights from both existing and novel features. Image analysis has great potential to identify, extract and quantify features in greater detail in comparison to pathologist assessment, which may produce improved prediction models or perform tasks beyond manual capability. In this article, we provide an overview of the utility of such technologies in clinical trials and provide a discussion of the potential applications, current challenges, limitations and remaining unanswered questions that require addressing prior to routine adoption in such studies. We reiterate the value of central review of pathology in clinical trials, and discuss inherent logistical, cost and performance advantages of using a digital approach. The current and emerging regulatory landscape is outlined. The role of digital platforms and remote learning to improve the training and performance of clinical trial pathologists is discussed. The impact of image analysis on quantitative tissue morphometrics in key areas such as standardisation of immunohistochemical stain interpretation, assessment of tumour cellularity prior to molecular analytical applications and the assessment of novel histological features is described. The standardisation of digital image production, establishment of criteria for digital pathology use in pre-clinical and clinical studies, establishment of performance criteria for image analysis algorithms and liaison with regulatory bodies to facilitate incorporation of image analysis applications into clinical practice are key issues to be addressed to improve digital pathology incorporation into clinical trials.
Text
Pell et al 2019 The Journal of Pathology-Clinical Research
- Version of Record
More information
Accepted/In Press date: 12 February 2019
e-pub ahead of print date: 15 February 2019
Keywords:
computerised image analysis, digital image analysis, digital microscopy
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Local EPrints ID: 430107
URI: http://eprints.soton.ac.uk/id/eprint/430107
PURE UUID: 9cb4e77b-c107-4aef-a72d-4b32a3f57fad
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Date deposited: 12 Apr 2019 16:30
Last modified: 16 Mar 2024 01:25
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Contributors
Author:
Robert Pell
Author:
Karin Oien
Author:
Max Robinson
Author:
Helen Pitman
Author:
Nasir Rajpoot
Author:
Jens Rittscher
Author:
David Snead
Author:
Clare Verrill
Corporate Author: On behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
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