Title
A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment
Abbreviated Journal Title
J. Natl. Cancer Inst.
Keywords
GROWTH-FACTOR RECEPTOR; CELL LUNG-CANCER; HER2-POSITIVE BREAST-CANCER; METASTATIC COLORECTAL-CANCER; CLINICAL-TRIAL DESIGN; ADJUVANT; CHEMOTHERAPY; PREDICTIVE MARKER; KRAS MUTATIONS; GENE-MUTATIONS; OVARIAN-CANCER; Oncology
Abstract
A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment. Participants agreed that critical decision points in the product life cycle depend on the level of understanding of the biology of the target and its interaction with the drug, the preanalytical and analytical factors affecting biomarker assay performance, and the clinical disease process. The more known about the biology and the greater the strength of association between an analytical signal and clinical result, the more efficient and less risky the development process will be. Rapid entry into clinical practice will only be achieved by using a rigorous scientific approach, including careful specimen collection and standardized and quality-controlled data collection. Early interaction with appropriate regulatory bodies will ensure studies are appropriately designed and biomarker test performance is well characterized.
Journal Title
Journal of the National Cancer Institute
Volume
101
Issue/Number
21
Publication Date
1-1-2009
Document Type
Article
Language
English
First Page
1453
Last Page
1463
WOS Identifier
ISSN
0027-8874
Recommended Citation
"A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment" (2009). Faculty Bibliography 2000s. 2219.
https://stars.library.ucf.edu/facultybib2000/2219
Comments
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