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 insufficient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We offer 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.
authors.affiliation: University of Michigan Comprehensive Cancer Center, Ann Arbor, MI 48109, USA. hayesdf@umich.edu
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Jeff
authors.initials: J
authors.lastname: Allen
authors.forename: Carolyn
authors.initials: C
authors.lastname: Compton
authors.forename: Gary
authors.initials: G
authors.lastname: Gustavsen
authors.forename: Debra G B
authors.initials: DG
authors.lastname: Leonard
authors.forename: Robert
authors.initials: R
authors.lastname: McCormack
authors.forename: Lee
authors.initials: L
authors.lastname: Newcomer
authors.forename: Kristin
authors.initials: K
authors.lastname: Pothier
authors.forename: David
authors.initials: D
authors.lastname: Ransohoff
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
authors.forename: Ellen
authors.initials: E
authors.lastname: Sigal
authors.forename: Sheila E
authors.initials: SE
authors.lastname: Taube
authors.forename: Sean R
authors.initials: SR
authors.lastname: Tunis
mesh_terms: D000818:Animals; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000191:economics; D035843:Biomedical Research / Q000191:economics / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis* / Q000378:metabolism; D017712:Peer Review, Research; D015203:Reproducibility of Results
chemical_list: D014408:Biomarkers, Tumor