title: Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
abstract: Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most efficiently, given the time- and cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the definition, validation, and qualification of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A flexible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging.
  
  
  BACKGROUND
  http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100800/-/DC1.
authors.affiliation: Buckler Biomedical, 13 Larch Row, Wenham, MA 01984, USA. andrew@bucklerbiomedical.com
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Buckler
authors.forename: Linda
authors.initials: L
authors.lastname: Bresolin
authors.forename: N Reed
authors.initials: NR
authors.lastname: Dunnick
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Sullivan
authors.forename: Hugo J W L
authors.initials: HJ
authors.lastname: Aerts
authors.forename: Bernard
authors.initials: B
authors.lastname: Bendriem
authors.forename: Claus
authors.initials: C
authors.lastname: Bendtsen
authors.forename: Ronald
authors.initials: R
authors.lastname: Boellaard
authors.forename: John M
authors.initials: JM
authors.lastname: Boone
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Cole
authors.forename: James J
authors.initials: JJ
authors.lastname: Conklin
authors.forename: Gary S
authors.initials: GS
authors.lastname: Dorfman
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.forename: Willy
authors.initials: W
authors.lastname: Eidsaunet
authors.forename: Cathy
authors.initials: C
authors.lastname: Elsinger
authors.forename: Richard A
authors.initials: RA
authors.lastname: Frank
authors.forename: Constantine
authors.initials: C
authors.lastname: Gatsonis
authors.forename: Maryellen L
authors.initials: ML
authors.lastname: Giger
authors.forename: Sandeep N
authors.initials: SN
authors.lastname: Gupta
authors.forename: David
authors.initials: D
authors.lastname: Gustafson
authors.forename: Otto S
authors.initials: OS
authors.lastname: Hoekstra
authors.forename: Edward F
authors.initials: EF
authors.lastname: Jackson
authors.forename: Lisa
authors.initials: L
authors.lastname: Karam
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Kelloff
authors.forename: Paul E
authors.initials: PE
authors.lastname: Kinahan
authors.forename: Geoffrey
authors.initials: G
authors.lastname: McLennan
authors.forename: Colin G
authors.initials: CG
authors.lastname: Miller
authors.forename: P David
authors.initials: PD
authors.lastname: Mozley
authors.forename: Keith E
authors.initials: KE
authors.lastname: Muller
authors.forename: Rick
authors.initials: R
authors.lastname: Patt
authors.forename: David
authors.initials: D
authors.lastname: Raunig
authors.forename: Mark
authors.initials: M
authors.lastname: Rosen
authors.forename: Haren
authors.initials: H
authors.lastname: Rupani
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Schwartz
authors.forename: Barry A
authors.initials: BA
authors.lastname: Siegel
authors.forename: A Gregory
authors.initials: AG
authors.lastname: Sorensen
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wahl
authors.forename: John C
authors.initials: JC
authors.lastname: Waterton
authors.forename: Walter
authors.initials: W
authors.lastname: Wolf
authors.forename: Gudrun
authors.initials: G
authors.lastname: Zahlmann
authors.forename: Brian
authors.initials: B
authors.lastname: Zimmerman
mesh_terms: D015415:Biomarkers; D035843:Biomedical Research / Q000458:organization & administration; D016265:Conflict of Interest; D018795:Device Approval; D003952:Diagnostic Imaging; D004059:Diffusion of Innovation; D005060:Europe; D006801:Humans; D011237:Predictive Value of Tests; D013673:Technology Assessment, Biomedical / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers