Article: article from journal or magazin.
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Pragmatic issues in biomarker evaluation for targeted therapies in cancer.
Nature Reviews. Clinical Oncology
Publication types: Journal Article ; Research Support, Non-U.S. Gov't ; ReviewPublication Status: ppublish
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.
Antineoplastic Agents/therapeutic use, Biomarkers, Tumor/metabolism, Drug Monitoring/methods, Humans, Molecular Targeted Therapy, Neoplasms/drug therapy, Prognosis, Reproducibility of Results
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