The Future Is Now: Model-Based Clinical Trial Design for Alzheimer’s Disease

K Romero; K Ito; J A Rogers; D Polhamus; R Qiu; D Stephenson; R Mohs; R Lalonde; V Sinha; Y Wang; D Brown; M Isaac; S Vamvakas; R Hemmings; L Pani; L J Bain; B Corrigan; Alzheimer's Disease Neuroimaging Initiative* for the Coalition Against Major Diseases

doi:10.1002/cpt.16

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Journal article

The Future Is Now: Model-Based Clinical Trial Design for Alzheimer’s Disease

K Romero, K Ito, J A Rogers, D Polhamus, R Qiu, D Stephenson, R Mohs, R Lalonde, V Sinha, Y Wang, …

Clinical pharmacology and therapeutics, Vol.97(3), pp.210-214

03/2015

DOI: 10.1002/cpt.16

PMCID: PMC6463482

PMID: 25669145

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Abstract

Failures in trials for Alzheimer’s disease (AD) may be attributable to inadequate dosing, population selection, drug inefficacy, or insufficient design optimization. The Coalition Against Major Diseases (CAMD) was formed in 2008 to develop drug development tools (DDT) to expedite drug development for AD and Parkinson’s disease. 1 CAMD led a process that successfully advanced a clinical trial simulation (CTS) tool for AD through the formal regulatory review process at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Details

Title: Subtitle: The Future Is Now: Model-Based Clinical Trial Design for Alzheimer’s Disease
Creators: K Romero - Critical Path Institute, Tucson, Arizone, USA
K Ito - Pfizer, Groton, Connecticut, USA
J A Rogers - Metrum Research Group, Tariffville, Connecticut, USA
D Polhamus - Metrum Research Group, Tariffville, Connecticut, USA
R Qiu - Pfizer, Groton, Connecticut, USA
D Stephenson - Critical Path Institute, Tucson, Arizone, USA
R Mohs - Eli Lilly, Lilly Corporate Center, Indianapolis, Indiana, USA
R Lalonde - Pfizer, Groton, Connecticut, USA
V Sinha - US Food and Drug Administration, Silver Spring, Maryland, USA
Y Wang - US Food and Drug Administration, Silver Spring, Maryland, USA
D Brown - European Medicines Agency, London, UK
M Isaac - European Medicines Agency, London, UK
S Vamvakas - European Medicines Agency, London, UK
R Hemmings - European Medicines Agency, London, UK
L Pani - European Medicines Agency, London, UK
L J Bain - Critical Path Institute, Tucson, Arizone, USA
B Corrigan - Pfizer, Groton, Connecticut, USA
Alzheimer's Disease Neuroimaging Initiative* for the Coalition Against Major Diseases
Contributors: Laura L Boles-Ponto (Contributor) - University of Iowa, Radiology
Resource Type: Journal article
Publication Details: Clinical pharmacology and therapeutics, Vol.97(3), pp.210-214
DOI: 10.1002/cpt.16
PMID: 25669145
PMCID: PMC6463482
NLM abbreviation: Clin Pharmacol Ther
ISSN: 0009-9236
eISSN: 1532-6535
Language: English
Date published: 03/2015
Academic Unit: Radiology; Pharmaceutical Sciences and Experimental Therapeutics
Record Identifier: 9984051731202771

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