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

Abstract:

: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.

journal_name

J Clin Psychopharmacol

authors

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

doi

10.1097/JCP.0b013e31823f3b47

subject

Has Abstract

pub_date

2012-02-01 00:00:00

pages

65-8

issue

1

eissn

0271-0749

issn

1533-712X

journal_volume

32

pub_type

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