The future is now: Model-based clinical trial design for Alzheimer's disease

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 developme...

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Veröffentlicht in:	Clinical pharmacology and therapeutics 2015-03, Vol.97 (3), p.210-214
Hauptverfasser:	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
Format:	Artikel
Sprache:	eng
Schlagworte:	Alzheimer Disease - drug therapy Clinical Trials as Topic - methods Computer Simulation Drug Approval - legislation & jurisprudence Drug Approval - methods Europe Humans United States United States Food and Drug Administration - legislation & jurisprudence
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Beschreibung
Zusammenfassung:	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).
ISSN:	0009-9236 1532-6535
DOI:	10.1002/cpt.16