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Training and accreditation standards for pathologists undertaking clinical trial work

Lookup NU author(s): Dr Max RobinsonORCiD, Professor Philip Sloan, Dr Andrew Hall



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© 2019 The Authors. The Journal of Pathology: Clinical Research published by The Pathological Society of Great Britain and Ireland and John Wiley & Sons Ltd.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.

Publication metadata

Author(s): Rees G, Salto-Tellez M, Lee JL, Oien K, Verrill C, Freeman A, Mirabile I, West NP, Cheang M, Rodriguez-Justo M, Howlett E, Moretti L, Da Silva M, Nacs W, Hartridge-Lambert S, Beecham JM, Traub S, Katugampola S, Blagden S, Morden J, Robinson M, James J, Jones LJ, Craig C, Sloan P, Thomas GJ, Elliott P, Driskell OJ, Hall A

Publication type: Article

Publication status: Published

Journal: Journal of Pathology: Clinical Research

Year: 2019

Pages: Epub ahead of print

Online publication date: 24/01/2019

Acceptance date: 20/01/2019

Date deposited: 20/03/2019

ISSN (print): 2056-4538

Publisher: John Wiley & Sons Ltd


DOI: 10.1002/cjp2.124


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Funder referenceFunder name
Cancer Research UK