Premium
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease
Author(s) -
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,
Bain Lisa,
Sampaio Cristina,
Raunig David,
Soares Holly,
Suhy Joyce,
Wang Huanli,
Wolz Robin,
Stephenson Diane
Publication year - 2014
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2013.07.003
Subject(s) - context (archaeology) , biomarker , agency (philosophy) , alzheimer's disease neuroimaging initiative , clinical trial , medicine , disease , alzheimer's disease , political science , pathology , geography , biology , social science , sociology , biochemistry , archaeology
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.