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Training and accreditation standards for pathologists undertaking clinical trial work

Training and accreditation standards for pathologists undertaking clinical trial work
Training and accreditation standards for pathologists undertaking clinical trial work

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.

clinical trials, NCRI CM-Path, training and accreditation
Rees, Gabrielle
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Salto-Tellez, Manuel
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Lee, Jessica L.
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Oien, Karin
e7577158-717e-42e4-b144-460763bbdc38
Verrill, Clare
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Freeman, Alex
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Mirabile, Ilaria
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West, Nicholas P.
8cee9b96-bc23-4b8e-8878-de92c122afe6
Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106
on behalf of the National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group
Rees, Gabrielle
f0e4fbc4-0e0e-4730-8b22-f4deca13ca26
Salto-Tellez, Manuel
df86e252-0d83-4456-a3ef-48b0a2b44b20
Lee, Jessica L.
0c9ab325-5fa3-4155-b61e-11c82a9a4e82
Oien, Karin
e7577158-717e-42e4-b144-460763bbdc38
Verrill, Clare
aebaa0d4-fb62-4bf6-97ab-5f9bb23cf9a3
Freeman, Alex
40ab3381-31c9-4660-8959-9c31e7377eec
Mirabile, Ilaria
f4589923-a34f-4b5e-9af6-1e3cdc01556c
West, Nicholas P.
8cee9b96-bc23-4b8e-8878-de92c122afe6
Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106

Rees, Gabrielle, Salto-Tellez, Manuel, Lee, Jessica L., Oien, Karin, Verrill, Clare, Freeman, Alex, Mirabile, Ilaria and West, Nicholas P. , on behalf of the National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group (2019) Training and accreditation standards for pathologists undertaking clinical trial work. Journal of Pathology: Clinical Research. (doi:10.1002/cjp2.124).

Record type: Article

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.

Text
Rees et al 2019 The Journal of Pathology-Clinical Research - Version of Record
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More information

Accepted/In Press date: 20 January 2019
e-pub ahead of print date: 24 January 2019
Keywords: clinical trials, NCRI CM-Path, training and accreditation

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Local EPrints ID: 430108
URI: http://eprints.soton.ac.uk/id/eprint/430108
PURE UUID: 7116800c-f574-43da-8c7d-8b5683255be4

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Date deposited: 12 Apr 2019 16:30
Last modified: 07 Oct 2020 00:30

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Contributors

Author: Gabrielle Rees
Author: Manuel Salto-Tellez
Author: Jessica L. Lee
Author: Karin Oien
Author: Clare Verrill
Author: Alex Freeman
Author: Ilaria Mirabile
Author: Nicholas P. West
Corporate Author: on behalf of the National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group

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