Breaking a vicious cycle

Daniel F. Hayes, Jef Allen, Carolyn Compton, Gary Gustavsen, Debra G.B. Leonard, Robert McCormack, Lee Newcomer, Kristin Pothier, David Ransohoff, Richard L. Schilsky, Ellen Sigal, Sheila E. Taube, Sean R. Tunis

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82 Scopus citations

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 vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders.

Original languageEnglish (US)
Article number196cm6
JournalScience Translational Medicine
Volume5
Issue number196
DOIs
StatePublished - Jul 31 2013

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hayes, D. F., Allen, J., Compton, C., Gustavsen, G., Leonard, D. G. B., McCormack, R., Newcomer, L., Pothier, K., Ransohoff, D., Schilsky, R. L., Sigal, E., Taube, S. E., & Tunis, S. R. (2013). Breaking a vicious cycle. Science Translational Medicine, 5(196), [196cm6]. https://doi.org/10.1126/scitranslmed.3005950