title: The role of the EORTC pathologist in clinical trials: achievements and perspectives. European Organisation for Research and Treatment of Cancer.
abstract: The role of the pathologist in clinical trials (CT) is focused on three activities: pathology review, translational research, and participation in scientific committees. The primary goal of pathology review in CT is the quality control (QC) of the diagnosis and prognostic parameters. Important contributions have been achieved in the context of QC for CT such as new classifications of diseases or identification of new prognostic markers that are now widely used. Telematics implemented in some EORTC groups markedly facilitate the pathology review. The pathologist has a key-role in translational research for the identification of new targets in tissue specimens that may eventually lead to new therapeutics and for the understanding of the mechanisms involved in tumour progression. The gap between individualised prognosis and therapeutical possibilities has been considerably reduced by the development of drugs targeted on specific molecular defects. The paradigm of this is the treatment of stromal tumours by STI-571. For proper selection of patients to be treated, information on the expression of the molecules involved is needed, which is well suited for pathologists. The access to tissue resources from patients included in CT is a major goal to enhance translational research, both for brand institution and CT organisations. Active involvement of pathologists in scientific committees and interactions with the pharmaceutical industry is mandatory for an optimal design of CT protocols. In addition, translational research is a resource-consuming activity that necessitates an adequate financial flow to create a proper infrastructure at least for sponsored trials to the participating pathology departments and committees.
authors.affiliation: Department of Pathology, Institut Gustave-Roussy, Villejuif, France. spatz@igr.fr
authors.forename: Alain
authors.initials: A
authors.lastname: Spatz
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: Ruiter
authors.forename: Christen
authors.initials: C
authors.lastname: Busch
authors.forename: Ivana
authors.initials: I
authors.lastname: Theodorovic
authors.forename: J Wolter
authors.initials: JW
authors.lastname: Oosterhuis
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D005060:Europe; D006801:Humans; D007390:International Agencies; D008495:Medical Oncology; D009369:Neoplasms / Q000473:pathology* / Q000628:therapy; D010336:Pathology / Q000379:methods; D010819:Physician's Role; D011786:Quality Control; D012107:Research Design