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Improving Alzheimer's disease phase II clinical trials
Author(s) -
Greenberg Barry D.,
Carrillo Maria C.,
Ryan J. Michael,
Gold Michael,
Gallagher Kim,
Grundman Michael,
Berman Robert M.,
Ashwood Timothy,
Siemers Eric R.
Publication year - 2013
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2012.02.002
Subject(s) - disease , drug development , government (linguistics) , clinical trial , medicine , drug , phase (matter) , pharmaceutical industry , intensive care medicine , business , pharmacology , linguistics , philosophy , chemistry , organic chemistry
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;6:107–8). 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.