title: Pathology is a necessary and informative tool in oncology clinical trials.
abstract: Clinical trials are essential for the improvement of cancer care. The complexity of modern cancer care and research require careful design, for which input from all disciplines is necessary. Pathologists should play a key role in the design and execution of modern cancer trials, with special attention to the eligibility, stratification and evaluation of response to therapy. In the current review all these aspects are discussed, with examples from colorectal cancer trials. We describe critical issues in biomarker evaluation and development and emphasize the importance of the role of the pathologist in quality control of cancer treatment.
authors.affiliation: Department of Pathology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: Iris D
authors.initials: ID
authors.lastname: Nagtegaal
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: West
authors.forename: J Han J M
authors.initials: JH
authors.lastname: van Krieken
authors.forename: Phil
authors.initials: P
authors.lastname: Quirke
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D023381:Endpoint Determination; D006801:Humans; D008495:Medical Oncology / Q000379:methods* / Q000592:standards; D009367:Neoplasm Staging; D009369:Neoplasms / Q000473:pathology* / Q000628:therapy*; D010338:Pathology, Clinical / Q000592:standards; D018579:Patient Selection; D011237:Predictive Value of Tests; D019984:Quality Indicators, Health Care; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome
keywords: clinical trials; end point; oncology; quality assurance; response; staging; stratification