TY - JOUR
T1 - Factors Associated with Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial
AU - CREST-2 Investigators
AU - Demaerschalk, Bart M.
AU - Brown, Robert D.
AU - Roubin, Gary S.
AU - Howard, Virginia J.
AU - Cesko, Eldina
AU - Barrett, Kevin M.
AU - Longbottom, Mary E.
AU - Voeks, Jenifer H.
AU - Chaturvedi, Seemant
AU - Brott, Thomas G.
AU - Lal, Brajesh K.
AU - Meschia, James F.
AU - Howard, George
N1 - Publisher Copyright:
© 2017 American Heart Association, Inc.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
AB - 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.
KW - carotid arteries
KW - carotid stenosis
KW - clinical trial
KW - endarterectomy, carotid
KW - multicenter study
KW - randomized controlled trial
KW - vascular diseases
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U2 - 10.1161/STROKEAHA.117.016976
DO - 10.1161/STROKEAHA.117.016976
M3 - Article
C2 - 28768800
AN - SCOPUS:85030425659
SN - 0039-2499
VL - 48
SP - 2511
EP - 2518
JO - Stroke
JF - Stroke
IS - 9
ER -