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Hill, Derek L.G.; Schwarz, Adam J.; Isaac, Maria; Pani, Luca; Vamvakas, Spiros; Hemmings, Robert; Carrillo, Maria C.; Yu, Peng; Sun, Jia; Beckett, Laurel; Boccardi, Marina; Brewer, James; Brumfield, Martha; Cantillon, Marc; Cole, Patricia E.; Fox, Nick; Frisoni, Giovanni B.; Jack, Clifford; Kelleher, Thomas; Luo, Feng; Novak, Gerald; Maguire, Paul; Meibach, Richard; Patterson, Patricia; [...]

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease

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  • Medientyp: E-Artikel
  • Titel: Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease
  • Beteiligte: Hill, Derek L.G.; Schwarz, Adam J.; Isaac, Maria; Pani, Luca; Vamvakas, Spiros; Hemmings, Robert; Carrillo, Maria C.; Yu, Peng; Sun, Jia; Beckett, Laurel; Boccardi, Marina; Brewer, James; Brumfield, Martha; Cantillon, Marc; Cole, Patricia E.; Fox, Nick; Frisoni, Giovanni B.; Jack, Clifford; Kelleher, Thomas; Luo, Feng; Novak, Gerald; Maguire, Paul; Meibach, Richard; Patterson, Patricia; [...]
  • Erschienen: Wiley, 2014
  • Erschienen in: Alzheimer's & Dementia
  • Sprache: Englisch
  • DOI: 10.1016/j.jalz.2013.07.003
  • ISSN: 1552-5260; 1552-5279
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Regulatory qualification of a biomarker for a defined context of use provides scientifically robust assurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion on the use of hippocampal volume as a biomarker for enriching clinical trials in subjects with mild cognitive impairment, incorporating a scientific rationale, a literature review and a de novo analysis of Alzheimer's Disease Neuroimaging Initiative data.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The literature review and de novo analysis were consistent with the proposed context of use, and the Committee for Medicinal Products for Human Use released an opinion in November 2011.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>We summarize the scientific rationale and the data that supported the first qualification of an imaging biomarker by the European Medicines Agency.</jats:p></jats:sec>