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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 was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. CONCLUSIONS:Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217.

journal_name

Stroke

journal_title

Stroke

authors

Demaerschalk BM,Brown RD Jr,Roubin GS,Howard VJ,Cesko E,Barrett KM,Longbottom ME,Voeks JH,Chaturvedi S,Brott TG,Lal BK,Meschia JF,Howard G,CREST-2 Investigators.

doi

10.1161/STROKEAHA.117.016976

subject

Has Abstract

pub_date

2017-09-01 00:00:00

pages

2511-2518

issue

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.117.016976

journal_volume

pub_type

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