title: Lost in translation: neuropsychiatric drug development.
abstract: Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.
authors.affiliation: Aristea Translational Medicine Corporation, Freeport, ME 04078, USA. rebecker2008@comcast.net
authors.forename: Robert E
authors.initials: RE
authors.lastname: Becker
authors.forename: Nigel H
authors.initials: NH
authors.lastname: Greig
mesh_terms: D000818:Animals; D015415:Biomarkers; D002491:Central Nervous System Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D004195:Disease Models, Animal; D015195:Drug Design; D017408:Guidelines as Topic; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy* / Q000503:physiopathology; D058027:Neuropsychiatry; D057170:Translational Research, Biomedical
chemical_list: D015415:Biomarkers; D002491:Central Nervous System Agents