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

doi:10.1126/scitranslmed.3005950

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

Research output: Contribution to journal › Article › peer-review

104 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 language	English (US)
Article number	196cm6
Journal	Science Translational Medicine
Volume	5
Issue number	196
DOIs	https://doi.org/10.1126/scitranslmed.3005950
State	Published - Jul 31 2013
Externally published	Yes

ASJC Scopus subject areas

Medicine(all)

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title = "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 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.",

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AU - Hayes, Daniel F.

AU - Allen, Jef

AU - Compton, Carolyn

AU - Gustavsen, Gary

AU - Leonard, Debra G.B.

AU - McCormack, Robert

AU - Newcomer, Lee

AU - Pothier, Kristin

AU - Ransohoff, David

AU - Schilsky, Richard L.

AU - Sigal, Ellen

AU - Taube, Sheila E.

AU - Tunis, Sean R.

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AB - 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.

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Breaking a vicious cycle

Abstract

ASJC Scopus subject areas

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