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Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience.
Zhao, Wenle; Yeatts, Sharon D; Broderick, Joseph P; Selim, Magdy H; Adeoye, Opeolu M; Durkalski-Mauldin, Valerie L; Meinzer, Caitlyn N; Martin, Reneé H; Dillon, Catherine R; Cassarly, Christy N; Pauls, Keith H; Elm, Jordan J.
Affiliation
  • Zhao W; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Yeatts SD; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Broderick JP; Departments of Neurology and Rehabilitation Medicine, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, OH (J.P.B.).
  • Selim MH; Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.H.S.).
  • Adeoye OM; Department of Emergency Medicine, Washington University School of Medicine, St. Louis, MO (O.M.A.).
  • Durkalski-Mauldin VL; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Meinzer CN; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Martin RH; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Dillon CR; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Cassarly CN; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Pauls KH; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
  • Elm JJ; Department of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
Stroke ; 54(7): 1909-1919, 2023 07.
Article in En | MEDLINE | ID: mdl-37078281
ABSTRACT
From 2016 to 2021, the National Institutes of Health Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke initiated ten multicenter randomized controlled clinical trials. Optimal subject randomization designs are demanded with 4 critical properties (1) protection of treatment assignment randomness, (2) achievement of the desired treatment allocation ratio, (3) balancing of baseline covariates, and (4) ease of implementation. For acute stroke trials, it is necessary to minimize the time between eligibility assessment and treatment initiation. This article reviews the randomization designs for 3 trials currently enrolling in Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke, the SATURN (Statins in Intracerebral Hemorrhage Trial), the MOST (Multiarm Optimization of Stroke Thrombolysis Trial), and the FASTEST (Recombinant Factor VIIa for Hemorrhagic Stroke Trial). Randomization methods utilized in these trials include minimal sufficient balance, block urn design, big stick design, and step-forward randomization. Their advantages and limitations are reviewed and compared with traditional stratified permuted block design and minimization.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Stroke / National Institute of Neurological Disorders and Stroke (U.S.) Type of study: Clinical_trials Limits: Humans Country/Region as subject: America do norte Language: En Journal: Stroke Year: 2023 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Stroke / National Institute of Neurological Disorders and Stroke (U.S.) Type of study: Clinical_trials Limits: Humans Country/Region as subject: America do norte Language: En Journal: Stroke Year: 2023 Document type: Article