2013
DOI: 10.1126/scitranslmed.3005950
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Breaking a Vicious Cycle

Abstract: Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insuf cient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vici… Show more

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Cited by 114 publications
(80 citation statements)
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“…4 Based on these and many other successes, recent groups have recommended that all prospective clinical trials include formalized biospecimen banking for use in this context. 5 Cooperative groups that participate in clinical trials can use the prospectiveretrospective model to share both aspects of investigationsubject enrollment, treatment, and analysis-as well as post hoc investigations of new questions.…”
mentioning
confidence: 99%
“…4 Based on these and many other successes, recent groups have recommended that all prospective clinical trials include formalized biospecimen banking for use in this context. 5 Cooperative groups that participate in clinical trials can use the prospectiveretrospective model to share both aspects of investigationsubject enrollment, treatment, and analysis-as well as post hoc investigations of new questions.…”
mentioning
confidence: 99%
“…He continues by saying that people need to value biomarker tests as much as they value drugs and that researchers should have to do a biomarker study with the same amount of rigor as therapeutic trials [10]. This opinion was also expressed by Hayes et al in a recent article published in Science Translational Medicine [11].…”
mentioning
confidence: 90%
“…Although there is still no absolute consensus regarding the representativity of the information obtained from circulating genetic material studies and there is an urgent need for techniques standardization, a considerable advance has been made [11]. Furthermore, following the identification of a potential novel biomarker, it has to undergo a validation process, consisting of three stages: the analytical validation, the clinical validation and the clinical utility [12] [13] [14] [15] [16]. Other aspect to be considered is the fact that CTCs do not constitute a homogeneous cell popula-tion even when coming from the same tumor.…”
Section: Circulating Tumor Cells (Ctcs)mentioning
confidence: 99%