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dc.contributor.authorPell, Ren_US
dc.contributor.authorOien, Ken_US
dc.contributor.authorRobinson, Men_US
dc.contributor.authorPitman, Hen_US
dc.contributor.authorRajpoot, Nen_US
dc.contributor.authorRittscher, Jen_US
dc.contributor.authorSnead, Den_US
dc.contributor.authorVerrill, Cen_US
dc.contributor.authorUK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working groupen_US
dc.date.accessioned2020-06-09T12:03:06Z
dc.date.issued2019-04
dc.identifier.citationThe journal of pathology. Clinical research, 2019, 5 (2), pp. 81 - 90
dc.identifier.issn2056-4538
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3718
dc.identifier.eissn2056-4538
dc.identifier.doi10.1002/cjp2.127
dc.description.abstractDigital 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.
dc.formatPrint-Electronic
dc.format.extent81 - 90
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectUK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
dc.subjectHumans
dc.subjectImage Interpretation, Computer-Assisted
dc.subjectMicroscopy
dc.subjectTelepathology
dc.subjectAlgorithms
dc.subjectImage Processing, Computer-Assisted
dc.subjectClinical Trials as Topic
dc.subjectPathologists
dc.titleThe use of digital pathology and image analysis in clinical trials.
dc.typeJournal Article
dcterms.dateAccepted2019-02-12
rioxxterms.versionofrecord10.1002/cjp2.127
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0
rioxxterms.licenseref.startdate2019-04
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe journal of pathology. Clinical research
pubs.issue2
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Genomic Analysis – Clinical Trials
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Integrated Pathology
pubs.publication-statusPublished
pubs.volume5
pubs.embargo.termsNot known
icr.researchteamGenomic Analysis – Clinical Trialsen_US
icr.researchteamIntegrated Pathologyen_US
dc.contributor.icrauthorCheang, Chonen
dc.contributor.icrauthorSalto-Tellez, Manuelen


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