TY - JOUR
T1 - Molecular prescreening to select patient population in early clinical trials
AU - Rodón, Jordi
AU - Saura, Cristina
AU - Dienstmann, Rodrigo
AU - Vivancos, Ana
AU - Ramón Y Cajal, Santiago
AU - Baselga, José
AU - Tabernero, Josep
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2012/6
Y1 - 2012/6
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84861730960&partnerID=8YFLogxK
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U2 - 10.1038/nrclinonc.2012.48
DO - 10.1038/nrclinonc.2012.48
M3 - Review article
C2 - 22473105
AN - SCOPUS:84861730960
SN - 1759-4774
VL - 9
SP - 359
EP - 366
JO - Nature Reviews Clinical Oncology
JF - Nature Reviews Clinical Oncology
IS - 6
ER -