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@ARTICLE{Boccardi:904297,
      author       = {Boccardi, Marina and Dodich, Alessandra and Albanese,
                      Emiliano and Gayet-Ageron, Angèle and Festari, Cristina and
                      Ashton, Nicholas J. and Bischof, Gérard N. and Chiotis,
                      Konstantinos and Leuzy, Antoine and Wolters, Emma E. and
                      Walter, Martin and Rabinovici, Gil D. and Carrillo, Maria
                      and Drzezga, Alexander and Hansson, Oskar and Nordberg,
                      Agneta and Ossenkoppele, Rik and Villemagne, Victor L. and
                      Winblad, Bengt and Frisoni, Giovanni and Garibotto,
                      Valentina},
      title        = {{T}he strategic biomarker roadmap for the validation of
                      {A}lzheimer’s diagnostic biomarkers: methodological
                      update},
      journal      = {European journal of nuclear medicine and molecular imaging},
      volume       = {48},
      number       = {13},
      issn         = {0340-6997},
      address      = {Heidelberg [u.a.]},
      publisher    = {Springer-Verl.},
      reportid     = {FZJ-2021-05867},
      pages        = {4525 - 4531},
      year         = {2021},
      abstract     = {Background: The 2017 Alzheimer's disease (AD) Strategic
                      Biomarker Roadmap (SBR) structured the validation of AD
                      diagnostic biomarkers into 5 phases, systematically
                      assessing analytical validity (Phases 1-2), clinical
                      validity (Phases 3-4), and clinical utility (Phase 5)
                      through primary and secondary Aims. This framework allows to
                      map knowledge gaps and research priorities, accelerating the
                      route towards clinical implementation. Within an initiative
                      aimed to assess the development of biomarkers of tau
                      pathology, we revised this methodology consistently with
                      progress in AD research.Methods: We critically appraised the
                      adequacy of the 2017 Biomarker Roadmap within current
                      diagnostic frameworks, discussed updates at a workshop
                      convening the Alzheimer's Association and 8 leading AD
                      biomarker research groups, and detailed the methods to allow
                      consistent assessment of aims achievement for tau and other
                      AD diagnostic biomarkers.Results: The 2020 update applies to
                      all AD diagnostic biomarkers. In Phases 2-3, we admitted a
                      greater variety of study designs (e.g., cross-sectional in
                      addition to longitudinal) and reference standards (e.g.,
                      biomarker confirmation in addition to clinical progression)
                      based on construct (in addition to criterion) validity. We
                      structured a systematic data extraction to enable
                      transparent and formal evidence assessment procedures.
                      Finally, we have clarified issues that need to be addressed
                      to generate data eligible to evidence-to-decision
                      procedures.Discussion: This revision allows for more
                      versatile and precise assessment of existing evidence, keeps
                      up with theoretical developments, and helps clinical
                      researchers in producing evidence suitable for
                      evidence-to-decision procedures. Compliance with this
                      methodology is essential to implement AD biomarkers
                      efficiently in clinical research and diagnostics.Keywords:
                      Alzheimer’s disease; Biomarker; Dementia; MCI; Mild
                      cognitive impairment; Validation methodology.},
      cin          = {INM-2},
      ddc          = {610},
      cid          = {I:(DE-Juel1)INM-2-20090406},
      pnm          = {5253 - Neuroimaging (POF4-525)},
      pid          = {G:(DE-HGF)POF4-5253},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {34546388},
      UT           = {WOS:000698040800001},
      doi          = {10.1007/s00259-021-05549-z},
      url          = {https://juser.fz-juelich.de/record/904297},
}