The Balance Comparison Among Simple Randomization, Stratified Blocked Randomization and Minimization_Chinese Journal of Evidence-Based Medicine

Authors：

YAN Shiyan ¹ ,  YAO Chen ² , XIA Jielai ¹

1.Department of Health Statistics, Faculty of Preventive Medicine, The Fourth Military Medical University, Xi’an 710032, China 2.Department of Medical Statistics, First Hospital of Peking University, Beijing 100034, China;

Corresponding author：

YAO Chen, Email: yaoc301@vip.sina.com

Keywords：

Randomization; Stratified blocked randomization; Dynamic randomization; Minimization; Clinical trials; Balance

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Objective 　To compare the balance of simple randomization, stratified blocked randomization and minimization.
Methods 　Monte Carlo technique was employed to simulate the treatment allocation of simple randomization, stratified blocked randomization and minimization respectively, then the balance of treatment allocation in each group and the balance for every prognostic factor were compared.
Results　 The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Balance in prognostic factors achieved with stratified blocked randomization was similar to that achieved with simple randomization.
Conclusion 　Minimization offers the best balance in the number of patients and prognostic factors between groups.

Citation： YAN Shiyan,YAO Chen,XIA Jielai. The Balance Comparison Among Simple Randomization, Stratified Blocked Randomization and Minimization. Chinese Journal of Evidence-Based Medicine, 2006, 06(5): 376-379. doi: Copy

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1. 张学中. 用区组和随机改进简单随机. 中国新药杂志, 2000; 9(10): 683～686.
2. 王倩, 金丕焕. 动态随机化在临床试验中的应用. 中华预防医学杂志, 2005;39(1): 51～53.
3. Zhang XZ. Improving simple randomization using blocking randomization. Chinese Journal of New Drug, 2000; 9(10): 683-686.
4. Wang Q, Jin PH. Utilization of dynamic randomization in clinical trial. Chinese Journal of Preventive Medicine, 2005; 39(1): 51-53.
5. Scott NW, McPherson GC, Ramsay CR, et al, The method of minimization for allocation to clinical trials. a review. Control Clin Trials, 2002; 23(6): 662-674.
6. Kernan WN, Viscoli CM, Makuch RW, et al. Stratified randomization for clinical trials. J Clin Epidemiol, 1999; 52(1): 19-26.
7. Hagino A, Hamada C, Yoshimura I, et al. Statistical comparison of random allocation methods in cancer clinical trials. Control Clin Trials, 2004; 25(6): 572-584.
8. McEntegart DJ. The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Inf J, 2003; 37: 293-308.
9. Pocock SJ, Simon R, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial, Biometrics, 1975; 31:103-105.

Chinese Journal of Evidence-Based Medicine

The Balance Comparison Among Simple Randomization, Stratified Blocked Randomization and Minimization

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