title: Study design in the evaluation of breast cancer imaging technologies.
abstract: OBJECTIVE
  Bringing a new imaging technology to market is a complex process. Beyond conceptualization and proof of concept, obtaining U.S. Food and Drug Administration (FDA) approval for clinical use depends on the documented experimental establishment of safety and efficacy. In turn, safety and efficacy are evaluated in the context of the intended use of the technology. The purpose of this study was to examine a conceptual framework for technology development and evaluation, focusing on new breast imaging technologies as a highly visible and current case in point.
  
  
  METHODS
  The FDA views technology development in terms of a preclinical and four clinical phases of assessment. With a concept of research and development as a learning model, this phased-assessment concept of regulatory review against intended use was integrated with a five-level version of a hierarchy-of-efficacy framework for evaluating imaging technologies. Study design and analysis issues are presented in this context, as are approaches to supporting expanded clinical indications and new intended uses after a new technology is marketed.
  
  
  CONCLUSIONS
  Breast imaging technologies may be intended for use as replacements for standard-of-care technologies, as adjuncts, or as complementary technologies. Study designs must be appropriate to establish claims of superiority or equivalence to the standard for the intended use. Screening technologies are ultimately judged on their demonstrated effectiveness in decreasing cause-specific mortality through early detection, but they may be brought to market for other uses on the basis of lesser standards of efficacy (eg, sensitivity, specificity, positive and negative predictive value, and stage of disease detected).
authors.affiliation: U.S. Food and Drug Administration, Rockville, MD 20852-0001, USA.
authors.forename: F
authors.initials: F
authors.lastname: Houn
authors.forename: R A
authors.initials: RA
authors.lastname: Bright
authors.forename: H F
authors.initials: HF
authors.lastname: Bushar
authors.forename: B Y
authors.initials: BY
authors.lastname: Croft
authors.forename: C A
authors.initials: CA
authors.lastname: Finder
authors.forename: J K
authors.initials: JK
authors.lastname: Gohagan
authors.forename: R J
authors.initials: RJ
authors.lastname: Jennings
authors.forename: P
authors.initials: P
authors.lastname: Keegan
authors.forename: L G
authors.initials: LG
authors.lastname: Kessler
authors.forename: B S
authors.initials: BS
authors.lastname: Kramer
authors.forename: L O
authors.initials: LO
authors.lastname: Martynec
authors.forename: M
authors.initials: M
authors.lastname: Robinowitz
authors.forename: W M
authors.initials: WM
authors.lastname: Sacks
authors.forename: D G
authors.initials: DG
authors.lastname: Schultz
authors.forename: R F
authors.initials: RF
authors.lastname: Wagner
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis*; D018795:Device Approval; D003952:Diagnostic Imaging / Q000592:standards*; D005260:Female; D006801:Humans; D012372:ROC Curve; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design; D013673:Technology Assessment, Biomedical / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration