Training and accreditation standards for pathologists undertaking clinical trial work

Rees, G., Salto-Tellez, M., Lee, J., Oien, K. , Verrill, C., Freeman, A., Mirabile, I. and West, N.P. (2019) Training and accreditation standards for pathologists undertaking clinical trial work. Journal of Pathology: Clinical Research, 5(2), pp. 100-107. (doi: 10.1002/cjp2.124) (PMID:30680942) (PMCID:PMC6463859)

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Abstract

Clinical trials rely on multidisciplinary teams for successful delivery. Pathologists should be involved in clinical trial design from the outset to ensure that protocols are optimised to deliver maximum data collection and translational research opportunities. Clinical trials must be performed according to the principles of Good Clinical Practice (GCP) and the trial sponsor has an obligation to ensure that all of the personnel involved in the trial have undergone training relevant to their role. Pathologists who are involved in the delivery of clinical trials are often required to undergo formal GCP training and may additionally undergo Good Clinical Laboratory Practice training if they are involved in the laboratory analysis of trials samples. Further training can be provided via trial-specific investigator meetings, which may be either multidisciplinary or discipline-specific events. Pathologists should also ensure that they undertake External Quality Assurance schemes relevant to the area of diagnostic practice required in the trial. The level of engagement of pathologists in academia and clinical trials research has declined in the United Kingdom over recent years. This paper recommends the optimal training and accreditation for pathologists undertaking clinical trials activities with the aim of facilitating increased engagement. Clinical trials training should ideally be provided to all pathologists through centrally organised educational events, with additional training provided to pathologists in training through local postgraduate teaching. Pathologists in training should also be strongly encouraged to undertake GCP training. It is hoped that these recommendations will increase the number of pathologists who take part in clinical trials research in order to ensure a high level and standard of data collection and to maximise the translational research opportunities.

Item Type:Articles
Additional Information:Funding Information: Bloodwise, Breast Cancer Now, Cancer Research UK Health and Care Research Wales (Welsh Government), Health and Social Care (Northern Ireland), Medical Research Council, Oxford NIHR Biomedical Research Centre, Prostate Cancer UK, Tenovus Cancer Care, Chief Scientist Office (Scotland), Department of Health (England), Yorkshire Cancer Research.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Oien, Professor Karin
Authors: Rees, G., Salto-Tellez, M., Lee, J., Oien, K., Verrill, C., Freeman, A., Mirabile, I., and West, N.P.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:Journal of Pathology: Clinical Research
Publisher:Wiley
ISSN:2056-4538
ISSN (Online):2056-4538
Published Online:27 February 2019
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in Journal of Pathology: Clinical Research 5:100-107
Publisher Policy:Reproduced under a creative commons licence

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