Bart M Demaerschalk1, Robert D Brown1, Gary S Roubin1, Virginia J Howard1, Eldina Cesko1, Kevin M Barrett1, Mary E Longbottom1, Jenifer H Voeks1, Seemant Chaturvedi1, Thomas G Brott2, Brajesh K Lal1, James F Meschia1, George Howard1. 1. From the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.). 2. From the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.). Brott.Thomas@mayo.edu.
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.
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.
Authors: Christina M Dording; Elizabeth D Dalton; Michael J Pencina; Maurizio Fava; David Mischoulon Journal: J Clin Psychopharmacol Date: 2012-02 Impact factor: 3.153
Authors: Diane Warden; Madhukar H Trivedi; Tracy L Greer; Edward Nunes; Bruce D Grannemann; Viviana E Horigian; Eugene Somoza; Kolette Ring; Tiffany Kyle; José Szapocznik Journal: Contemp Clin Trials Date: 2011-09-17 Impact factor: 2.226
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: J T Wright; W C Cushman; B R Davis; J Barzilay; P Colon; D Egan; T Lucente; C Nwachuku; S Pressel; F H Leenen; J Frolkis; R Letterer; S Walsh; J N Tobin; G E Deger Journal: Control Clin Trials Date: 2001-12
Authors: Jennifer Sharpe Potter; Dennis M Donovan; Roger D Weiss; John Gardin; Robert Lindblad; Paul Wakim; Dorian Dodd Journal: Am J Drug Alcohol Abuse Date: 2011-09 Impact factor: 3.829
Authors: Virginia J Howard; James F Meschia; Brajesh K Lal; Tanya N Turan; Gary S Roubin; Robert D Brown; Jenifer H Voeks; Kevin M Barrett; Bart M Demaerschalk; John Huston; Ronald M Lazar; Wesley S Moore; Virginia G Wadley; Seemant Chaturvedi; Claudia S Moy; Marc Chimowitz; George Howard; Thomas G Brott Journal: Int J Stroke Date: 2017-05-02 Impact factor: 5.266
Authors: Inmaculada B Aban; Gil I Wolfe; Gary R Cutter; Henry J Kaminski; Alfred Jaretzki; Greg Minisman; Robin Conwit; John Newsom-Davis Journal: J Neuroimmunol Date: 2008-09-15 Impact factor: 3.478
Authors: Sarah Berk; Brittany L Greco; Kevin Biglan; Catherine M Kopil; Robert G Holloway; Claire Meunier; Tanya Simuni Journal: J Parkinsons Dis Date: 2017 Impact factor: 5.568