title: Why so few drugs for Alzheimer's disease? Are methods failing drugs?
abstract: Recent studies of Alzheimer's disease (AD) and other neuropsychiatric drug developments raise questions whether failures of some drugs occur due to flaws in methods. In three case studies of recent AD drug development failures with phenserine, metrifonate, and tarenflurbil we identified methodological lapses able to account for the failures. Errors in complex systems such as drug developments are both almost inescapable due to human mistakes and most frequently hidden at the time of occurrence and thereafter. We propose preemptive error management as a preventive strategy to exclude or control error intrusions into neuropsychiatric drug developments. We illustrate the functions we anticipate for a preemptive error management preventive strategy with a checklist and identify the limitations of this aspect of the proposal with three drug examples. This strategy applies core scientific practices to insure the quality of data within the current context of AD drug development practices.
authors: Drug Design & Development Section, Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD 21224, USA.
authors: R E
authors: RE
authors: Becker
authors: N H
authors: NH
authors: Greig
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000639:trends; D004341:Drug Evaluation / Q000379:methods* / Q000592:standards* / Q000639:trends; D006801:Humans; D018696:Neuroprotective Agents / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D018696:Neuroprotective Agents