Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations

• Published in: BMC medical research methodology Vol. 24; no. 1; pp. 52 - 23
• Main Authors: Sverdlov, Oleksandr, Ryeznik, Yevgen, Anisimov, Volodymyr, Kuznetsova, Olga M., Knight, Ruth, Carter, Kerstine, Drescher, Sonja, Zhao, Wenle
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 28.02.2024; BioMed Central; BMC
• Subjects: Allocation randomness; Clinical trials; Design; Evaluation; Humans; Information management; Maximum tolerated imbalance; Medical research; Medicine, Experimental; Monte Carlo simulation; Multi-center clinical trial; Patient Selection; Patients; Poisson-gamma model; Random Allocation; Random variables; Recruitment time; Research Design; Research methodology; Sample Size; United States; Multi-center clinical trial; Poisson-gamma model; Allocation randomness; Recruitment time; Maximum tolerated imbalance

The design of a multi-center randomized controlled trial (RCT) involves multiple considerations, such as the choice of the sample size, the number of centers and their geographic location, the strategy for recruitment of study participants, amongst others. There are plenty of methods to sequentially...