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Schizophrenia Bulletin Advance Access originally published online on May 20, 2008
Schizophrenia Bulletin 2008 34(4):656-663; doi:10.1093/schbul/sbn042
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© The Author 2008. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

Richard S. E. Keefe1,2 and Philip D. Harvey3
2 Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 3270, Durham, NC 27710
3 Department of Psychiatry, Emory University School of Medicine, 101 Woodruff Circle, Suite 4000, Atlanta, GA 30322, US

1 To whom correspondence should be addressed; tel: (919) 684-4306, fax: (919) 684-2632, e-mail: richard.keefe{at}duke.edu.

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.

Keywords: schizophrenia / clinical trials / cognition


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