Pragmatic issues in biomarker evaluation for targeted therapies in cancer.
Journal article

Pragmatic issues in biomarker evaluation for targeted therapies in cancer.

  • de Gramont A New Drug Evaluation Laboratory, Centre of Experimental Therapeutics, Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), 1011 Lausanne, Switzerland.
  • Watson S INSERM U830, Genetics and Biology of Paediatric Tumours Group, Institut Curie, France.
  • Ellis LM Departments of Surgical Oncology, and Molecular and Cellular Oncology, University of Texas MD Anderson Cancer Center, USA.
  • Rodón J Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO) and Universitat Autonoma de Barcelona (UAB), Spain.
  • Tabernero J Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO) and Universitat Autonoma de Barcelona (UAB), Spain.
  • de Gramont A Medical Oncology Department, Institut Hospitalier Franco-Britannique, France.
  • Hamilton SR Division of Pathology and Laboratory Medicine, University of Texas MD Anderson Cancer Center, USA.
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  • 2014-11-26
Published in:
  • Nature reviews. Clinical oncology. - 2015
English Predictive biomarkers are becoming increasingly important tools in drug development and clinical research. The importance of using both guidelines for specimen acquisition and analytical methods for biomarker measurements that are standardized has become recognized widely as an important issue, which must be addressed in order to provide high-quality, validated assays. Herein, we review the major challenges in biomarker validation processes, including pre-analytical (sample-related), analytical, and post-analytical (data-related) aspects of assay development. Recommendations for improving biomarker assay development and method validation are proposed to facilitate the use of predictive biomarkers in clinical trials and the practice of oncology.
Language
  • English
Open access status
closed
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Persistent URL
https://folia.unifr.ch/global/documents/20310
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