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Evaluating Tests of Cognition using a Computerized Touch-Sensitive Tablet, Eye Tracking, and Functional Magnetic Resonance Imaging
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Implementation considerations for multisite clinical trials with cognitive neuroscience tasks.

Richard S E Keefe1, Philip D Harvey

  • 1Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 3270, Durham, NC 27710, USA. richard.keefe@duke.edu

Schizophrenia Bulletin
|May 23, 2008
PubMed
Summary

Multisite clinical trials face challenges with standard cognitive tests and even more with cognitive neuroscience (CN) procedures. Ensuring tester competence and data quality are key for reliable results in neuropsychiatric research.

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Area of Science:

  • Clinical Neuroscience
  • Cognitive Psychology
  • Psychiatric Research

Background:

  • Multisite clinical trials frequently utilize standard neuropsychological tests for cognitive enhancement outcomes in neuropsychiatric conditions.
  • These established tests are reliable and predictive of functional disability but present implementation challenges in trial settings.

Purpose of the Study:

  • To identify and address implementation challenges in multisite clinical trials, particularly concerning cognitive assessment methods.
  • To anticipate magnified difficulties with emerging cognitive neuroscience (CN) procedures in future multisite studies.

Main Methods:

  • Analysis of implementation challenges associated with standard neuropsychological tests in multisite clinical trials.
  • Projection of challenges for less standardized and more complex cognitive neuroscience procedures in future trials.

Main Results:

  • Standard tests face issues like tester competence, performance monitoring, and data quality assurance.
  • Cognitive neuroscience procedures are expected to exacerbate these challenges due to lower standardization and increased complexity.

Conclusions:

  • Key challenges for multisite trials include assuring tester competence, monitoring performance, managing complex assessments, and ensuring data quality.
  • Proactive strategies are needed to overcome these implementation hurdles for successful cognitive assessment in clinical trials.