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Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work

Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work
Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work

While pathologists have always played a pivotal role in clinical trials ensuring accurate diagnosis and staging, pathology data from prognostic and predictive tests are increasingly being used to enrol, stratify and randomise patients to experimental treatments. The use of pathological parameters as primary and secondary outcome measures, either as standalone classifiers or in combination with clinical data, is also becoming more common. Moreover, reporting of estimates of residual disease, termed ‘pathological complete response’, have been incorporated into neoadjuvant clinical trials. Pathologists have the expertise to deliver this essential information and they also understand the requirements and limitations of laboratory testing. Quality assurance of pathology-derived data builds confidence around trial-specific findings and is necessarily focused on the reproducibility of pathological data, including ‘estimates of uncertainty of measurement’, emphasising the importance of pathologist education, training, calibration and demonstration of satisfactory inter-observer agreement. There are also opportunities to validate objective image analysis tools alongside conventional histological assessments. The ever-expanding portfolio of clinical trials will demand more pathologist engagement to deliver the reliable evidence-base required for new treatments. We provide guidance for quality assurance of pathology scoring and reporting in clinical trials.

biomarkers, clinical trials, immunohistochemistry, pathology, quality assurance
91-99
Robinson, Max
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James, Jacqueline
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Thomas, Gareth
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West, Nicholas
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Jones, Louise
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Lee, Jessica
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Oien, Karin
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Freeman, Alex
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Craig, Clare
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Sloan, Philip
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Elliot, Philip
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Cheang, Maggie
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Rodriguez-Justo, Manuel
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Verrill, Clare
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on behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group
Robinson, Max
1cd9b30b-4ddc-4cd1-b165-8c958fac393d
James, Jacqueline
ca777d29-3f9e-4c93-9a9b-3c05af12cd73
Thomas, Gareth
2ff54aa9-a766-416b-91ee-cf1c5be74106
West, Nicholas
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Jones, Louise
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Lee, Jessica
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Oien, Karin
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Freeman, Alex
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Craig, Clare
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Sloan, Philip
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Elliot, Philip
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Cheang, Maggie
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Rodriguez-Justo, Manuel
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Verrill, Clare
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on behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group (2019) Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work. Journal of Pathology: Clinical Research, 5 (2), 91-99. (doi:10.1002/cjp2.121).

Record type: Article

Abstract

While pathologists have always played a pivotal role in clinical trials ensuring accurate diagnosis and staging, pathology data from prognostic and predictive tests are increasingly being used to enrol, stratify and randomise patients to experimental treatments. The use of pathological parameters as primary and secondary outcome measures, either as standalone classifiers or in combination with clinical data, is also becoming more common. Moreover, reporting of estimates of residual disease, termed ‘pathological complete response’, have been incorporated into neoadjuvant clinical trials. Pathologists have the expertise to deliver this essential information and they also understand the requirements and limitations of laboratory testing. Quality assurance of pathology-derived data builds confidence around trial-specific findings and is necessarily focused on the reproducibility of pathological data, including ‘estimates of uncertainty of measurement’, emphasising the importance of pathologist education, training, calibration and demonstration of satisfactory inter-observer agreement. There are also opportunities to validate objective image analysis tools alongside conventional histological assessments. The ever-expanding portfolio of clinical trials will demand more pathologist engagement to deliver the reliable evidence-base required for new treatments. We provide guidance for quality assurance of pathology scoring and reporting in clinical trials.

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Accepted/In Press date: 1 November 2018
e-pub ahead of print date: 8 November 2018
Published date: 1 April 2019
Keywords: biomarkers, clinical trials, immunohistochemistry, pathology, quality assurance

Identifiers

Local EPrints ID: 430670
URI: http://eprints.soton.ac.uk/id/eprint/430670
PURE UUID: e8d5c45b-f5ed-4ab4-8564-673d1172a35d

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Date deposited: 08 May 2019 16:30
Last modified: 07 Oct 2020 00:59

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Contributors

Author: Max Robinson
Author: Jacqueline James
Author: Gareth Thomas
Author: Nicholas West
Author: Louise Jones
Author: Jessica Lee
Author: Karin Oien
Author: Alex Freeman
Author: Clare Craig
Author: Philip Sloan
Author: Philip Elliot
Author: Maggie Cheang
Author: Manuel Rodriguez-Justo
Author: Clare Verrill
Corporate Author: on behalf of the UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group

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