Abstract
Background 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. Methods 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. Results 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. Conclusions We summarize the scientific rationale and the data that supported the first qualification of an imaging biomarker by the European Medicines Agency.
Original language | English |
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Pages (from-to) | 421-429 |
Number of pages | 9 |
Journal | Alzheimer's and Dementia |
Volume | 10 |
Issue number | 4 |
DOIs | |
Publication status | Published - 2014 |
Keywords
- Alzheimer's disease
- Alzheimer's Disease Neuroimaging Initiative
- Hippocampal volume
- Mild cognitive impairment
ASJC Scopus subject areas
- Clinical Neurology
- Developmental Neuroscience
- Cellular and Molecular Neuroscience
- Psychiatry and Mental health
- Geriatrics and Gerontology
- Epidemiology
- Health Policy