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. 2017 Sep;48(9):2511-2518.
doi: 10.1161/STROKEAHA.117.016976. Epub 2017 Aug 2.

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

Bart M Demaerschalk  1 , Robert D Brown Jr  1 , Gary S Roubin  1 , Virginia J Howard  1 , Eldina Cesko  1 , Kevin M Barrett  1 , Mary E Longbottom  1 , Jenifer H Voeks  1 , Seemant Chaturvedi  1 , Thomas G Brott  2 , Brajesh K Lal  1 , James F Meschia  1 , George Howard  1 ; CREST-2 Investigators
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Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial

Bart M Demaerschalk et al. Stroke. 2017 Sep.

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.

Keywords: carotid arteries; carotid stenosis; clinical trial; endarterectomy, carotid; multicenter study; randomized controlled trial; vascular diseases.

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Figures

Figure 1
Figure 1
Figure 1A and 1B: The proportion of sites approved for randomization (green lighted sites) as a function of time since approval by the site selection committee (left panel), also shown by participation in the previously-conducted CREST trial (right panel).
Figure 1
Figure 1
Figure 1A and 1B: The proportion of sites approved for randomization (green lighted sites) as a function of time since approval by the site selection committee (left panel), also shown by participation in the previously-conducted CREST trial (right panel).
Figure 2
Figure 2
Figure 2A and 2B: The proportion of sites approved for randomization that had randomized one or more patients as a function of time since approval for randomization (left panel), also shown by whether the site was approved for randomization only in the CEA plus intensive medical management vs intensive medical management study, only in the CAS plus intensive medical management versus intensive medical management study, or in both studies.
Figure 2
Figure 2
Figure 2A and 2B: The proportion of sites approved for randomization that had randomized one or more patients as a function of time since approval for randomization (left panel), also shown by whether the site was approved for randomization only in the CEA plus intensive medical management vs intensive medical management study, only in the CAS plus intensive medical management versus intensive medical management study, or in both studies.
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