Year: 2016
Type: article
Abstract: The discovery of reliable biomarkers to predict efficacy and toxicity of anticancer drugs remains one of the key challenges in cancer research. Despite its relevance, no efficient study designs to identify promising candidate biomarkers have been established. This has led to the proliferation of a myriad of exploratory studies using dissimilar strategies, most of which fail to identify any promising targets and are seldom validated. The lack of a proper methodology also determines that many anti-cancer drugs are developed below their potential, due to failure to identify predictive biomarkers. While some drugs will be systematically administered to many patients who will not benefit from them, leading to unnecessary toxicities and costs, others will never reach registration due to our inability to identify the specific patient population in which they are active. Despite these drawbacks, a limited number of outstanding predictive biomarkers have been successfully identified and validated, and have changed the standard practice of oncology. In this manuscript, a multidisciplinary panel reviews how those key biomarkers were identified and, based on those experiences, proposes a methodological framework-the DESIGN guidelines-to standardize the clinical design of biomarker identification studies and to develop future research in this pivotal field.
Source: Cancer Treatment Reviews
Authors: Jose Luis Perez-Gracia, Miguel F. Sanmamed, Ana Bosch, Ana Patiño-Garcia, Kurt A. Schalper, Victor Segura, Joaquim Bellmunt, Josep Tabernero, Christopher J. Sweeney, Toni K. Choueiri, Miguel Martín, Juan Pablo Fusco, Maria Esperanza Rodriguez-Ruiz, Alfonso Calvo, Celia Prior, Luis Paz-Ares, Ruben Pio, Enrique Gonzalez-Billalabeitia, Alvaro Gonzalez Hernandez, David Páez, Jose María Piulats, Alfonso Gurpide, Mapi Andueza, Guillermo de Velasco, Roberto Pazo, Enrique Grande, Pilar Nicolas, Francisco Abad-Santos, Jesus Garcia-Donas, Daniel Castellano, María J. Pajares, Cristina Suarez, Ramon Colomer, Luis M. Montuenga, Ignacio Melero
Institutions: Navarre Institute of Health Research, Clinica Universidad de Navarra, Universidad de Navarra, Yale University, Lund University, Centro de Investigación Médica Aplicada, Harvard University, Dana-Farber Cancer Institute, Universitat Autònoma de Barcelona, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, Hospital Universitario 12 De Octubre, Hospital General Universitario Morales Meseguer, Universidad Católica de Murcia, Hospital de Sant Pau, Institut Català d'Oncologia, Hospital Universitario Miguel Servet, Hospital Universitario Ramón y Cajal, University of the Basque Country, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, HM Hospitales
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $4,910
OpenAlex ID: W2564717375