Clinical trials in oncology are important tools to identify and establish new effective drugs for cancer treatment. Since the development of the concept of precision oncology, a huge number of multi-centric biomarker-driven clinical trials have been performed and promoted by either academic institutions or pharmaceutical companies. In this scenario, the role of pathologists is essential in multiple aspects, with new challenges that should be addressed. In this position paper of the European Society of Pathology, the role of pathologists as contributors to the design of the clinical trial, as local collaborators, or as members of central review laboratories is discussed. Moreover, the paper emphasizes the important role of pathologists in guiding methods and criteria of tissue biomarker testing in the biomarker-driven clinical trials. The paper also addresses issues regarding quality control, training, and the possible role of digital pathology.

Department of Pathology Forensic and Insurance Medicine Semmelweis University Budapest Budapest Hungary

European Society of Pathology Brussels Belgium

Histopathology and Molecular Diagnostics University Hospital Careggi Florence Italy

Hospital U de Bellvitge IDIBELL University of Barcelona Barcelona Spain

Hospital Universitari Arnau de Vilanova Universitat de Lleida IRBLleida CIBERONC Lleida Spain

Institute of Pathology University Hospital Heidelberg Germany

The Fingerland Department of Pathology Charles University Medical Faculty and University Hospital Hradec Kralove Czech Republic

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https://ecis.jrc.ec.europa.eu/

https://www.clinicaltrialsregister.eu/ctr-search/search?query=cancer

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