AI Article Synopsis
- Regulatory qualification of biomarkers ensures reliability for drug development, aiding both sponsors and regulators in the process.
- The Coalition Against Major Diseases presented data to the European Medicines Agency to qualify hippocampal volume as a useful biomarker for clinical trials involving mild cognitive impairment.
- The review and analysis backed the proposed use, leading to the successful qualification of an imaging biomarker by the European Medicines Agency in 2011.
Article 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.
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| http://dx.doi.org/10.1016/j.jalz.2013.07.003 | DOI Listing |
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