The application of dynamical stratified blocked randomization algorithm in clinical randomized controlled trials_Chinese Journal of Evidence-Based Medicine

Authors：

WEN Tiancai ^1,2 ^# , HE Liyun ² ^# , YAN Shiyan ² ,  ZHANG Yanning ¹

1. School of Computer Science, Northwestern Polytechnical University, Xi'an, 710129, P.R.China;
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, P.R.China;

Corresponding author：

ZHANG Yanning, Email: ynzhang@nwpu.edu.cn

Keywords：

Dynamical stratified blocked randomization; Competition enrolment; Clinical research; Gastric cancer; Traditional Chinese Medicine

DOI：

10.7507/1672-2531.201711017

Video：

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This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.

Citation： WEN Tiancai, HE Liyun, YAN Shiyan, ZHANG Yanning. The application of dynamical stratified blocked randomization algorithm in clinical randomized controlled trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 758-762. doi: 10.7507/1672-2531.201711017 Copy

1.	Lin Y, Zhu M, Zheng S. The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials. Contemp Clin Trials, 2015(Pt A), 45: 21-25.
2.	万霞, 刘建平. 临床试验中的随机分组方法. 中医杂志, 2007, 48(3): 216-219.
3.	Bellamy SL. A dynamic block-randomization algorithm for group-randomized clinical trials when the composition of blocking factors is not known in advance. Contemp Clin Trials, 2005, 26(4): 469-79.
4.	Xiao L, Lavori PW, Wilson SR, et al. Comparison of dynamic block randomization and minimization in randomized trials: a simulation study. Clin Trials, 2011; 8(1): 59-69.
5.	刘保延, 文天才, 姚晨, 等. 多中心临床试验中的中央随机系统研究. 中国新药与临床杂志, 2006, 25(12): 931-934.
6.	Sedgwick P. Controlled trials: allocation concealment, random allocation, and blinding. BMJ, 2015, 350(2): h2633.
7.	Beksinska ME, Joanis C, Smit JA, et al. Using scratch card technology for random allocation concealment in a clinical trial with a crossover design. Clinical Trials, 2013, 10(1): 125-130.
8.	钟伟华, 陆梦洁, 刘玉秀, 等. 随机分配簿: 实现临床试验随机分配遮蔽的新技术. 医学研究生学报, 2017, 30(1): 91-94.
9.	李星锐, 张艳燕, 杨小平, 等. 中央随机网络系统的应用探讨. 辽宁中医杂志, 2012, 39(6): 1055-1057.
10.	李庚, 李晓彦, 禤美玲, 等. 随机双盲临床对照试验中编盲及药物动态管理的规范化操作. 中国循证医学杂志, 2015, 15(5): 607-611.
11.	闫世艳, 何丽云, 文天才, 等. 双盲临床试验中动态药物编盲方法. 中医杂志, 2013, 54(12): 1004-1006.
12.	曹放, 王慧, 张颖, 等. 基于中央随机化的药物配送建模方法研究. 中国药房, 2009, 20(34): 2714-2716.
13.	刘川. 药物临床试验方法学. 北京: 化学工业出版社, 2011: 511-512.
14.	闫世艳, 姚晨, 夏结来. 简单随机化、中心分层区组随机化和最小化法的均衡性比较. 中国循证医学杂志, 2006, 6(5): 376-379.

1. Lin Y, Zhu M, Zheng S. The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials. Contemp Clin Trials, 2015(Pt A), 45: 21-25.
2. 万霞, 刘建平. 临床试验中的随机分组方法. 中医杂志, 2007, 48(3): 216-219.
3. Bellamy SL. A dynamic block-randomization algorithm for group-randomized clinical trials when the composition of blocking factors is not known in advance. Contemp Clin Trials, 2005, 26(4): 469-79.
4. Xiao L, Lavori PW, Wilson SR, et al. Comparison of dynamic block randomization and minimization in randomized trials: a simulation study. Clin Trials, 2011; 8(1): 59-69.
5. 刘保延, 文天才, 姚晨, 等. 多中心临床试验中的中央随机系统研究. 中国新药与临床杂志, 2006, 25(12): 931-934.
6. Sedgwick P. Controlled trials: allocation concealment, random allocation, and blinding. BMJ, 2015, 350(2): h2633.
7. Beksinska ME, Joanis C, Smit JA, et al. Using scratch card technology for random allocation concealment in a clinical trial with a crossover design. Clinical Trials, 2013, 10(1): 125-130.
8. 钟伟华, 陆梦洁, 刘玉秀, 等. 随机分配簿: 实现临床试验随机分配遮蔽的新技术. 医学研究生学报, 2017, 30(1): 91-94.
9. 李星锐, 张艳燕, 杨小平, 等. 中央随机网络系统的应用探讨. 辽宁中医杂志, 2012, 39(6): 1055-1057.
10. 李庚, 李晓彦, 禤美玲, 等. 随机双盲临床对照试验中编盲及药物动态管理的规范化操作. 中国循证医学杂志, 2015, 15(5): 607-611.
11. 闫世艳, 何丽云, 文天才, 等. 双盲临床试验中动态药物编盲方法. 中医杂志, 2013, 54(12): 1004-1006.
12. 曹放, 王慧, 张颖, 等. 基于中央随机化的药物配送建模方法研究. 中国药房, 2009, 20(34): 2714-2716.
13. 刘川. 药物临床试验方法学. 北京: 化学工业出版社, 2011: 511-512.
14. 闫世艳, 姚晨, 夏结来. 简单随机化、中心分层区组随机化和最小化法的均衡性比较. 中国循证医学杂志, 2006, 6(5): 376-379.

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The application of dynamical stratified blocked randomization algorithm in clinical randomized controlled trials

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