Comparison of academic and nonacademic sites in multi-center clinical trials.

Journal Article

The selection of appropriate subjects is a critical element of successful clinical trials. Failure to properly identify, select, and retain subjects in clinical trials of antidepressant medications may affect the ability to show separation from placebo. Little is known about which type of site, academic or nonacademic, is superior in selecting and retaining appropriate subjects. In the present investigation, the authors conducted a retrospective analysis comparing the performance of academic and nonacademic sites in selecting and retaining appropriate subjects in a recently completed multi-site clinical study of aripiprazole augmentation. The authors used a set of operationalized criteria called the SAFER to identify appropriate study subjects. No significant differences were found in rates of SAFER interview passing, study completion, and clinical outcomes between academic and nonacademic sites. Our findings suggest that academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.

Full Text

Duke Authors

Cited Authors

  • Dording, CM; Dalton, ED; Pencina, MJ; Fava, M; Mischoulon, D

Published Date

  • February 2012

Published In

Volume / Issue

  • 32 / 1

Start / End Page

  • 65 - 68

PubMed ID

  • 22198440

Electronic International Standard Serial Number (EISSN)

  • 1533-712X

Digital Object Identifier (DOI)

  • 10.1097/JCP.0b013e31823f3b47

Language

  • eng

Conference Location

  • United States