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  • Perez-Gracia, Jose LuisUniversity Clinic of Navarra,Health Research Institute of Navarra (IDISNA) (author)

Strategies to design clinical studies to identify predictive biomarkers in cancer research

  • Article/chapterEnglish2017

Publisher, publication year, extent ...

  • Elsevier BV,2017

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:d6c3669d-f7c3-4e6e-bceb-ef0be5a05b8b
  • https://lup.lub.lu.se/record/d6c3669d-f7c3-4e6e-bceb-ef0be5a05b8bURI
  • https://doi.org/10.1016/j.ctrv.2016.12.005DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:for swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • 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.

Subject headings and genre

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  • Sanmamed, Miguel F.Yale University (author)
  • Bosch Campos, AnaLund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylära behandlingsstrategier vid bröstcancer,Forskargrupper vid Lunds universitet,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular therapeutics in breast cancer,Lund University Research Groups(Swepub:lu)med-abp (author)
  • Patiño-Garcia, AnaHealth Research Institute of Navarra (IDISNA),University Clinic of Navarra (author)
  • Schalper, Kurt A.Yale University (author)
  • Segura, VictorUniversity of Navarra (author)
  • Bellmunt, JoaquimDana-Farber Cancer Institute (author)
  • Tabernero, JosepVall d'Hebron University Hospital (author)
  • Sweeney, Christopher J.Dana-Farber Cancer Institute (author)
  • Choueiri, Toni K.Dana-Farber Cancer Institute (author)
  • Martín, MiguelComplutense University of Madrid (author)
  • Fusco, Juan PabloUniversity Clinic of Navarra (author)
  • Rodriguez-Ruiz, Maria EsperanzaUniversity of Navarra (author)
  • Calvo, AlfonsoHealth Research Institute of Navarra (IDISNA),University of Navarra (author)
  • Prior, CeliaUniversity of Navarra (author)
  • Paz-Ares, Luis12 de Octubre University Hospital (author)
  • Pio, RubenUniversity of Navarra,Health Research Institute of Navarra (IDISNA) (author)
  • Gonzalez-Billalabeitia, EnriqueHospital General Universitario Morales Meseguer (author)
  • Gonzalez Hernandez, AlvaroUniversity Clinic of Navarra (author)
  • Páez, DavidHospital de Sant Pau (author)
  • Piulats, Jose MaríaCatalan Institute of Oncology (author)
  • Gurpide, AlfonsoHealth Research Institute of Navarra (IDISNA) (author)
  • Andueza, MapiUniversity Clinic of Navarra (author)
  • Velasco, GuillermoDana-Farber Cancer Institute (author)
  • Pazo, RobertoMiguel Servet University Hospital (author)
  • Grande, EnriqueHospital Ramón Y Cajal (author)
  • Nicolas, PilarUniversity of the Basque Country (author)
  • Abad-Santos, FranciscoHospital Universitario de la Princesa (author)
  • Garcia-Donas, JesusAutonomous University of Madrid (author)
  • Castellano, Daniel12 de Octubre University Hospital (author)
  • Pajares, María J.Health Research Institute of Navarra (IDISNA),University of Navarra (author)
  • Suarez, CristinaVall d'Hebron University Hospital (author)
  • Colomer, RamonHospital Universitario de la Princesa (author)
  • Montuenga, Luis M.University of Navarra,Health Research Institute of Navarra (IDISNA) (author)
  • Melero, IgnacioUniversity Clinic of Navarra,University of Navarra,Health Research Institute of Navarra (IDISNA) (author)
  • University Clinic of NavarraHealth Research Institute of Navarra (IDISNA) (creator_code:org_t)

Related titles

  • In:Cancer Treatment Reviews: Elsevier BV53, s. 79-970305-7372

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