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The future is now: Model‐based clinical trial design for Alzheimer's disease
Author(s) -
Romero K,
Ito K,
Rogers JA,
Polhamus D,
Qiu R,
Stephenson D,
Mohs R,
Lalonde R,
Sinha V,
Wang Y,
Brown D,
Isaac M,
Vamvakas S,
Hemmings R,
Pani L,
Bain LJ,
Corrigan B
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.16
Subject(s) - food and drug administration , clinical trial , drug development , disease , medicine , drug , dosing , intensive care medicine , agency (philosophy) , clinical study design , population , regulatory agency , clinical pharmacology , risk analysis (engineering) , pharmacology , environmental health , pathology , political science , philosophy , epistemology , public administration
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).