title: Pragmatic issues in biomarker evaluation for targeted therapies in cancer.
abstract: Predictive biomarkers are becoming increasingly important tools in drug development and clinical research. The importance of using both guidelines for specimen acquisition and analytical methods for biomarker measurements that are standardized has become recognized widely as an important issue, which must be addressed in order to provide high-quality, validated assays. Herein, we review the major challenges in biomarker validation processes, including pre-analytical (sample-related), analytical, and post-analytical (data-related) aspects of assay development. Recommendations for improving biomarker assay development and method validation are proposed to facilitate the use of predictive biomarkers in clinical trials and the practice of oncology.
authors.affiliation: New Drug Evaluation Laboratory, Centre of Experimental Therapeutics, Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), 1011 Lausanne, Switzerland.
authors.forename: Armand
authors.initials: A
authors.lastname: de Gramont
authors.affiliation: INSERM U830, Genetics and Biology of Paediatric Tumours Group, Institut Curie, France.
authors.forename: Sarah
authors.initials: S
authors.lastname: Watson
authors.affiliation: Departments of Surgical Oncology, and Molecular and Cellular Oncology, University of Texas MD Anderson Cancer Center, USA.
authors.forename: Lee M
authors.initials: LM
authors.lastname: Ellis
authors.affiliation: Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO) and Universitat Autonoma de Barcelona (UAB), Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Rodón
authors.affiliation: Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO) and Universitat Autonoma de Barcelona (UAB), Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
authors.affiliation: Medical Oncology Department, Institut Hospitalier Franco-Britannique, France.
authors.forename: Aimery
authors.initials: A
authors.lastname: de Gramont
authors.affiliation: Division of Pathology and Laboratory Medicine, University of Texas MD Anderson Cancer Center, USA.
authors.forename: Stanley R
authors.initials: SR
authors.lastname: Hamilton
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism*; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy*; D011379:Prognosis; D015203:Reproducibility of Results
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor