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The use of digital pathology and image analysis in clinical trials

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
1cd9b30b-4ddc-4cd1-b165-8c958fac393d
Pitman, Helen
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Rajpoot, Nasir
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Rittscher, Jens
a2037278-6051-4ee9-a16e-b7707dc9bbdc
Snead, David
021cdb53-bac3-4107-85f8-df3fd9a270bd
Verrill, Clare
aebaa0d4-fb62-4bf6-97ab-5f9bb23cf9a3
Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106
On behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
Pell, Robert
fa64c347-5d55-492b-a859-8e3022cb7e05
Oien, Karin
e7577158-717e-42e4-b144-460763bbdc38
Robinson, Max
1cd9b30b-4ddc-4cd1-b165-8c958fac393d
Pitman, Helen
d0afa224-0538-4e0c-9611-378569f58d8e
Rajpoot, Nasir
07a8eeae-7827-4e95-8ba8-085bc409b34c
Rittscher, Jens
a2037278-6051-4ee9-a16e-b7707dc9bbdc
Snead, David
021cdb53-bac3-4107-85f8-df3fd9a270bd
Verrill, Clare
aebaa0d4-fb62-4bf6-97ab-5f9bb23cf9a3
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).

Record type: Review

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
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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

Identifiers

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: 07 Oct 2020 00:44

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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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