Implementation considerations for multisite clinical trials with cognitive neuroscience tasks.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Keefe, RSE; Harvey, PD

Published Date

  • July 2008

Published In

Volume / Issue

  • 34 / 4

Start / End Page

  • 656 - 663

PubMed ID

  • 18495645

Pubmed Central ID

  • PMC2632463

International Standard Serial Number (ISSN)

  • 0586-7614

Digital Object Identifier (DOI)

  • 10.1093/schbul/sbn042


  • eng

Conference Location

  • United States