Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

ABSTRACT:

Background and purpose

Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection.

Methods

In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type.

Results

For 147 sites, the median time between site selection to authorization to randomize

SUBMITTER: Demaerschalk BM 

PROVIDER: S-EPMC5575963 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature