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The strategic biomarker roadmap for the validation of Alzheimer’s diagnostic biomarkers : methodological update

Boccardi, Marina ; Dodich, Alessandra ; Albanese, Emiliano ; Gayet-Ageron, Angèle ; Festari, Cristina ; Ashton, Nicholas J. ; Bischof, Gérard N. ; Chiotis, Konstantinos ; Leuzy, Antoine LU and Wolters, Emma E. , et al. (2021) In European Journal of Nuclear Medicine and Molecular Imaging
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... (More)

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.

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@article{98224d39-1a6f-4015-921d-f5be6e2d9b8d,
  abstract     = {<p>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.</p>},
  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 A. 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 B. and Garibotto, Valentina},
  issn         = {1619-7070},
  language     = {eng},
  publisher    = {Springer},
  series       = {European Journal of Nuclear Medicine and Molecular Imaging},
  title        = {The strategic biomarker roadmap for the validation of Alzheimer’s diagnostic biomarkers : methodological update},
  url          = {http://dx.doi.org/10.1007/s00259-020-05120-2},
  doi          = {10.1007/s00259-020-05120-2},
  year         = {2021},
}