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

Robinson, M. et al. (2019) Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work. Journal of Pathology: Clinical Research, 5(2), pp. 91-99. (doi: 10.1002/cjp2.121) (PMID:30407751) (PMCID:PMC6463860)

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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.

Item Type:Articles
Additional Information:Funding Information: National Cancer Research Institute.
Glasgow Author(s) Enlighten ID:Oien, Professor Karin
Authors: Robinson, M., James, J., Thomas, G., West, N., Jones, L., Lee, J., Oien, K., Freeman, A., Craig, C., Sloan, P., Elliot, P., Cheang, M., Rodriguez-Justo, M., and Verrill, C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:Journal of Pathology: Clinical Research
ISSN (Online):2056-4538
Published Online:29 November 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in Journal of Pathology: Clinical Research 5:91-99
Publisher Policy:Reproduced under a creative commons licence

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