title: Molecular prescreening to select patient population in early clinical trials.
abstract: The efficacy of targeted therapies in patient populations selected for treatment on the basis of the molecular features of their tumours is shifting the current focus of treatment to biomarker-driven clinical trials. Phase I trials provide an arena for early hypothesis testing, examining not only safety and toxicity, but also target engagement, biologically effective dosages, and the appropriate patient population. In this Perspectives article, we describe this new trend in early drug development, establishing the different approaches for building a pre-screening programme in an academic institution that is involved in early drug development. Our experience establishing the phase I programme at Vall d'Hebrón serves as an example of how these approaches can be integrated in ongoing trials, and we believe these considerations will help others to implement similar programmes in their institutions.
authors.affiliation: Medical Oncology Department, Vall d'Hebrón University Hospital, Spain. jrodon@vhio.net
authors.forename: Jordi
authors.initials: J
authors.lastname: Rodón
authors.forename: Cristina
authors.initials: C
authors.lastname: Saura
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Dienstmann
authors.forename: Ana
authors.initials: A
authors.lastname: Vivancos
authors.forename: Santiago
authors.initials: S
authors.lastname: Ramón y Cajal
authors.forename: José
authors.initials: J
authors.lastname: Baselga
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D015507:Drugs, Investigational / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D012107:Research Design
chemical_list: D015507:Drugs, Investigational