TY - JOUR
T1 - Biospecimens, biomarkers, and burgeoning data
T2 - The imperative for more rigorous research standards
AU - Poste, George
PY - 2012/12
Y1 - 2012/12
N2 - Knowledge of the altered molecular landscapes in disease offers great promise for developing biomarker-based tests to improve diagnosis and optimize treatment. Progress in biomarker research has been frustratingly slow due to the poor clinical trial design and the lack of standards for specimen collection, biomarker analysis, and data reporting. The ability of high throughput genomics, proteomics, and other 'omics' platforms to profile a large number of analytes in a single assay, together with the pending prospect of rapid expansion of whole exome and whole genome sequencing for clinical use, is increasing the technical and logistical complexity of biomarker validation. Harnessing these new technologies and improved productivity in biomarker validation will depend on adopting systems-based approaches and require major changes in the organization and funding strategies for biomarker research. A systems approach will require new multi-institution collaborations, the integration of diverse technical and clinical activities, greater engagement of industry, and education of regulators, clinicians, and payers about how to use biomarkers for improved patient management and clinical outcomes.
AB - Knowledge of the altered molecular landscapes in disease offers great promise for developing biomarker-based tests to improve diagnosis and optimize treatment. Progress in biomarker research has been frustratingly slow due to the poor clinical trial design and the lack of standards for specimen collection, biomarker analysis, and data reporting. The ability of high throughput genomics, proteomics, and other 'omics' platforms to profile a large number of analytes in a single assay, together with the pending prospect of rapid expansion of whole exome and whole genome sequencing for clinical use, is increasing the technical and logistical complexity of biomarker validation. Harnessing these new technologies and improved productivity in biomarker validation will depend on adopting systems-based approaches and require major changes in the organization and funding strategies for biomarker research. A systems approach will require new multi-institution collaborations, the integration of diverse technical and clinical activities, greater engagement of industry, and education of regulators, clinicians, and payers about how to use biomarkers for improved patient management and clinical outcomes.
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U2 - 10.1016/j.molmed.2012.09.003
DO - 10.1016/j.molmed.2012.09.003
M3 - Review article
C2 - 23122852
AN - SCOPUS:84870245866
SN - 1471-4914
VL - 18
SP - 717
EP - 722
JO - Trends in Molecular Medicine
JF - Trends in Molecular Medicine
IS - 12
ER -