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

Author:

Robinson Max1ORCID,James Jacqueline2,Thomas Gareth3,West Nicholas4ORCID,Jones Louise5,Lee Jessica6,Oien Karin7,Freeman Alex8,Craig Clare9,Sloan Philip10,Elliot Philip5,Cheang Maggie11,Rodriguez‐Justo Manuel12,Verrill Clare13,

Affiliation:

1. Centre for Oral Health ResearchNewcastle University Newcastle upon Tyne UK

2. School of Medicine, Dentistry and Biomedical SciencesCentre for Cancer Research and Cell Biology, Institute for Health Sciences, Queen's University Belfast Belfast UK

3. Faculty of Medicine Cancer Sciences UnitSouthampton University Southampton UK

4. Pathology and Tumour BiologyLeeds Institute of Cancer and Pathology, University of Leeds Leeds UK

5. Centre for Tumour BiologyBarts Cancer Institute, Barts and the London School of Medicine and Dentistry London UK

6. Strategy and InitiativesNational Cancer Research Institute London UK

7. Institute of Cancer Sciences – PathologyUniversity of Glasgow Glasgow UK

8. Department of PathologyUniversity College London Hospitals NHS Foundation Trust London UK

9. Genomics England London UK

10. Department of Cellular PathologyNewcastle upon Tyne Hospitals NHS Trust Newcastle upon Tyne UK

11. Institute of Cancer Research Clinical Trials and Statistics UnitThe Institute of Cancer Research Surrey UK

12. Department of GastroenterologyUniversity College Hospitals London London UK

13. Nuffield Department of Surgical SciencesUniversity of Oxford, and Oxford NIHR Biomedical Research Centre Oxford UK

Funder

National Cancer Research Institute

Publisher

Wiley

Subject

Pathology and Forensic Medicine

Reference31 articles.

1. Digital pathology and image analysis in tissue biomarker research

2. Morphomolecular pathology: setting the framework for a new generation of pathologists

3. Best Practices Guideline: Toxicologic Histopathology

4. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification. Guidance for Industry.2016. [Accessed 6 August 2018]. Available from:https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285297.pdf.

5. Recommendations for Pathology Peer Review

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