Training and accreditation standards for pathologists undertaking clinical trial work.
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Date
2019-04-01ICR Author
Author
Rees, G
Salto-Tellez, M
Lee, JL
Oien, K
Verrill, C
Freeman, A
Mirabile, I
West, NP
National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group,
Type
Journal Article
Metadata
Show full item recordAbstract
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.
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Subject
National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) clinical trials working group
Humans
Reproducibility of Results
Pathology, Clinical
Research Personnel
Laboratories
Accreditation
United Kingdom
Pathologists
Research team
Genomic Analysis – Clinical Trials
Integrated Pathology
Language
eng
Date accepted
2019-01-20
License start date
2019-04
Citation
The journal of pathology. Clinical research, 2019, 5 (2), pp. 100 - 107
Publisher
WILEY