TY - JOUR
T1 - Optimal Randomization Designs for Large Multicenter Clinical Trials
T2 - From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience
AU - Zhao, Wenle
AU - Yeatts, Sharon D.
AU - Broderick, Joseph P.
AU - Selim, Magdy H.
AU - Adeoye, Opeolu M.
AU - Durkalski-Mauldin, Valerie L.
AU - Meinzer, Caitlyn N.
AU - Martin, Reneé H.
AU - Dillon, Catherine R.
AU - Cassarly, Christy N.
AU - Pauls, Keith H.
AU - Elm, Jordan J.
N1 - Publisher Copyright:
© 2023 American Heart Association, Inc.
PY - 2023/7/1
Y1 - 2023/7/1
N2 - 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.
AB - 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.
KW - allocation randomness
KW - covariate balance
KW - emergency treatment
KW - multicenter clinical trial
KW - randomization
KW - response adaptive randomization
UR - http://www.scopus.com/inward/record.url?scp=85163647521&partnerID=8YFLogxK
U2 - 10.1161/STROKEAHA.122.040743
DO - 10.1161/STROKEAHA.122.040743
M3 - Review article
C2 - 37078281
AN - SCOPUS:85163647521
SN - 0039-2499
VL - 54
SP - 1909
EP - 1919
JO - Stroke
JF - Stroke
IS - 7
ER -