title: Implementation considerations for multisite clinical trials with cognitive neuroscience tasks.
abstract: Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 3270, Durham, NC 27710, USA. richard.keefe@duke.edu
authors.forename: Richard S E
authors.initials: RS
authors.lastname: Keefe
authors.forename: Philip D
authors.initials: PD
authors.lastname: Harvey
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D003072:Cognition Disorders / Q000175:diagnosis* / Q000188:drug therapy*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards*; D009483:Neuropsychological Tests / Q000592:standards / Q000706:statistics & numerical data*; D009488:Neurosciences / Q000193:education / Q000379:methods*; D011594:Psychometrics; D012106:Research / Q000193:education; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D012108:Research Personnel / Q000193:education / Q000592:standards; D012559:Schizophrenia / Q000175:diagnosis* / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D013647:Task Performance and Analysis