Improving Alzheimer's disease phase II clinical trials.
Alzheimers Dement
; 9(1): 39-49, 2013 Jan.
Article
em En
| MEDLINE
| ID: mdl-23164548
ABSTRACT
Over the past 30 years, many drugs have been studied as possible treatments for Alzheimer's disease, but only four have demonstrated sufficient efficacy to be approved as treatments, of which three are in the same class. This lack of success has raised questions both in the pharmaceutical industry and academia about the future of Alzheimer's disease therapy. The high cost and low success rate of drug development across many disease areas can be attributed, in large part, to late-stage clinical failures (Schachter and Ramoni, Nat Rev Drug Discov 2007;6107-8). Thus, identifying in phase II, or preferably phase I, drugs that are likely to fail would have a dramatic impact on the costs associated with developing new drugs. With this in mind, the Alzheimer's Association convened a Research Roundtable on June 23 and 24, 2011, in Washington, DC, bringing together scientists from academia, industry, and government regulatory agencies to discuss strategies for improving the probability of phase II trial results predicting success when considering the go/no-go decision-making process leading to the initiation of phase III.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Fase II como Assunto
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Fármacos Neuroprotetores
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Doença de Alzheimer
Tipo de estudo:
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Alzheimers Dement
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Canadá