Strategies to design clinical studies to identify predictive biomarkers in cancer research
Perez-Gracia, Jose Luis (Clínica Universidad de Navarra)
Sanmamed, Miguel F. (Yale University School of Medicine)
Bosch, Ana (Lund University)
Patiño-Garcia, Ana (Clínica Universidad de Navarra)
Schalper, Kurt A. (Yale School of Medicine)
Segura, Victor (Universidad de Navarra)
Bellmunt, Joaquim (Dana-Farber Cancer Institute and Harvard Medical School)
Tabernero, Josep (Hospital Universitari Vall d'Hebron)
Sweeney, Christopher J. (Dana-Farber Cancer Institute and Harvard Medical School)
Choueiri, Toni K. (Dana-Farber Cancer Institute and Harvard Medical School)
Martín Jiménez, Miguel (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Fusco, Juan Pablo (Clínica Universidad de Navarra)
Rodriguez-Ruiz, Maria Esperanza (Universidad de Navarra)
Calvo, Alfonso (Universidad de Navarra)
Prior, Celia (Universidad de Navarra)
Paz-Ares, Luis (Hospital Universitario 12 de Octubre (Madrid))
Pio, Ruben (Universidad de Navarra)
Gonzalez-Billalabeitia, Enrique (Universidad Católica San Antonio de Murcia)
Gonzalez Hernandez, Alvaro (Clínica Universidad de Navarra)
Páez, David (Institut d'Investigació Biomèdica Sant Pau)
Piulats, Jose María (Institut Català d'Oncologia)
Gurpide, Alfonso (Universidad de Navarra)
Andueza, Mapi (Clínica Universidad de Navarra)
de Velasco, Guillermo (Dana-Farber Cancer Institute and Harvard Medical School)
Pazo, Roberto (Hospital Universitario Miguel Servet (Saragossa))
Grande, Enrique (Hospital Universitario Ramón y Cajal (Madrid))
Nicolas, Pilar (Universidad del País Vasco)
Abad-Santos, Francisco (Instituto de Investigación Sanitaria la Princesa (IP))
Garcia-Donas, Jesus (Centro Integral Oncológico HM Clara Campal)
Castellano, Daniel (Hospital Universitario 12 de Octubre (Madrid))
Pajares, María J. (Universidad de Navarra)
Suárez, Cristina (Hospital Universitari Vall d'Hebron)
Colomer, Ramon (Hospital Universitario de la Princesa (Madrid))
Montuenga, Luis M. (Universidad de Navarra)
Melero, Ignacio (Universidad de Navarra)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Ressenya ; recerca ; Versió publicada
Publicat a:	Cancer Treatment Reviews, Vol. 53 (january 2017) , p. 79-97, ISSN 1532-1967

DOI: 10.1016/j.ctrv.2016.12.005

19 p, 1.6 MB

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