title: The future is now: model-based clinical trial design for Alzheimer's disease.
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. 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).
authors: Critical Path Institute, Tucson, Arizona, USA.
authors: K
authors: K
authors: Romero
authors: K
authors: K
authors: Ito
authors: J A
authors: JA
authors: Rogers
authors: D
authors: D
authors: Polhamus
authors: R
authors: R
authors: Qiu
authors: D
authors: D
authors: Stephenson
authors: R
authors: R
authors: Mohs
authors: R
authors: R
authors: Lalonde
authors: V
authors: V
authors: Sinha
authors: Y
authors: Y
authors: Wang
authors: D
authors: D
authors: Brown
authors: M
authors: M
authors: Isaac
authors: S
authors: S
authors: Vamvakas
authors: R
authors: R
authors: Hemmings
authors: L
authors: L
authors: Pani
authors: L J
authors: LJ
authors: Bain
authors: B
authors: B
authors: Corrigan
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D005060:Europe; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence