Adaptive randomization and its application in clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

QIAN Zhenzhen ^1,2 , ZHOU Sha ² , YU Yanan ² ,  GAO Rui ³ , JING Zhiwei ²

1. Postdoctoral Research Station of China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
2. Institute of Basic Clinical Medicine of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, P. R. China;

Corresponding author：

GAO Rui, Email: drjzw@163.com

Keywords：

Adaptive design; Random allocation; Adaptive randomization

DOI：

10.7507/1672-2531.202203007

Video：

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Randomization was the basis for the design and conduct of clinical trials. However, the traditional randomized controlled trials (RCTs) were often randomized in a fixed manner with unbalanced potential covariates, which spured researchers to develop a more flexible and practical randomization method. Thus, the adaptive randomization emerged as the time needed. In this paper, the application of adaptive randomization in clinical trials was introduced, and its key points of implementation, advantages and disadvantages were summarized. The development space of the adaptive randomization in clinical applications was also discussed, and it provided evidence for the development of the drug clinical trials in China.

Citation： QIAN Zhenzhen, ZHOU Sha, YU Yanan, GAO Rui, JING Zhiwei. Adaptive randomization and its application in clinical trials. Chinese Journal of Evidence-Based Medicine, 2022, 22(8): 971-977. doi: 10.7507/1672-2531.202203007 Copy

1.	王维亭, 郝春华, 汤立达. 临床适应性设计及在新药研发中的应用. 现代药物与临床, 2010, 25(5): 334-339.
2.	于莉莉, 薛富波, 王素珍, 等. 临床试验适应性设计的反应变量-适应性随机化方法简介. 中国卫生统计, 2008, 25(5): 534-536,538.
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5.	Thompson WR. On the likelihood that one unknown probability exceeds another in view of the evidence of two samples. Biometrika, 1933, 25(3-4): 285-294.
6.	王雨宁, 徐畅, 邹康, 等. 临床试验中适应性随机化的应用. 中国循证医学杂志, 2020, 20(5): 616-620.
7.	Hu J, Zhu H, Hu F. A unified family of covariate-adjusted response-adaptive designs based on efficiency and ethics. J Am Stat Assoc, 2015, 110(509): 357-367.
8.	Hu F, Rosenberger WF. The theory of response-adaptive randomization in clinical trials. Hoboken: John Wiley & Sons, 2006.
9.	Soares JF, Wu CFJ. Some restricted randomization rules in sequential designs. Commun Stat Theory Methods, 1983, 12(17): 2017-2034.
10.	Higham R, Tharmanathan P, Birks Y. Use and reporting of restricted randomization: a review. J Eval Clin Pract, 2015, 21(6): 1205-1211.
11.	Rosenberger WF, Sverdlov O, Hu F. Adaptive randomization for clinical trials. J Biopharm Stat, 2012, 22(4): 719-736.
12.	Hodges D. Design for the control of selection bias. Ann Math Stat, 1957, 28(2): 449-460.
13.	Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials, 1988, 9(4): 312-326.
14.	袁阳丹. 限制性和协变量适应性随机化方法性能研究. 广州: 南方医科大学, 2020.
15.	Wang T, Ma W. The impact of misclassification on covariate-adaptive randomized clinical trials. Biometrics, 2021, 77(2): 451-464.
16.	Li X, Zhou J, Hu F. Testing hypotheses under adaptive randomization with continuous covariates in clinical trials. Stat Methods Med Res, 2019, 28(6): 1609-1621.
17.	Zagoraiou M. Choosing a covariate-adaptive randomization procedure in practice. J Biopharm Stat, 2017, 27(5): 845-857.
18.	Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther, 1974, 15(5): 443-453.
19.	Baldi AA, Zagoraiou M. The covariate-adaptive biased coin design for balancing clinical trials in the presence of prognostic factors. Biometrika, 98: 519-535.
20.	Qiao W, Ning J, Huang X. A clinical trial design with covariate-adjusted response-adaptive randomization using superiority confidence of treatments. Stat Biopharm Res, 2019, 11(4): 336-347.
21.	Scordo MG, Pengo V, Spina E, et al. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on warfarin maintenance dose and metabolic clearance. Clin Pharmacol Ther, 2002, 72(6): 702-710.
22.	Rosenberger WF, Vidyashankar AN, Agarwal DK. Covariate adjusted response adaptive designs for binary responses. J Biopharm Stat, 11: 227-236.
23.	Bandyopadhyay U, Bhattacharya R. An urn based covariate adjusted response adaptive allocation design. Stat Methods Med Res, 2012, 21(2): 135-148.
24.	Proschan M, Evans S. Resist the Temptation of Response-Adaptive Randomization. Clin Infect Dis, 2020, 71(11): 3002-3004.
25.	Hewitt CE, Torgerson DJ. Is restricted randomisation necessary. BMJ, 2006, 332(7556): 1506-1508.

1. 王维亭, 郝春华, 汤立达. 临床适应性设计及在新药研发中的应用. 现代药物与临床, 2010, 25(5): 334-339.
2. 于莉莉, 薛富波, 王素珍, 等. 临床试验适应性设计的反应变量-适应性随机化方法简介. 中国卫生统计, 2008, 25(5): 534-536,538.
3. 刘甜甜. 临床试验随机化方法的优化研究. 广州: 南方医科大学, 2018.
4. 国家药品监督管理局药品评审中心. 药物临床试验随机分配指导原则(试行), 2021. Available at: https://www.cde.org.cn/main/att/download/e0dbbd6e531c314bcfd5ab5eb1817b12.
5. Thompson WR. On the likelihood that one unknown probability exceeds another in view of the evidence of two samples. Biometrika, 1933, 25(3-4): 285-294.
6. 王雨宁, 徐畅, 邹康, 等. 临床试验中适应性随机化的应用. 中国循证医学杂志, 2020, 20(5): 616-620.
7. Hu J, Zhu H, Hu F. A unified family of covariate-adjusted response-adaptive designs based on efficiency and ethics. J Am Stat Assoc, 2015, 110(509): 357-367.
8. Hu F, Rosenberger WF. The theory of response-adaptive randomization in clinical trials. Hoboken: John Wiley & Sons, 2006.
9. Soares JF, Wu CFJ. Some restricted randomization rules in sequential designs. Commun Stat Theory Methods, 1983, 12(17): 2017-2034.
10. Higham R, Tharmanathan P, Birks Y. Use and reporting of restricted randomization: a review. J Eval Clin Pract, 2015, 21(6): 1205-1211.
11. Rosenberger WF, Sverdlov O, Hu F. Adaptive randomization for clinical trials. J Biopharm Stat, 2012, 22(4): 719-736.
12. Hodges D. Design for the control of selection bias. Ann Math Stat, 1957, 28(2): 449-460.
13. Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials, 1988, 9(4): 312-326.
14. 袁阳丹. 限制性和协变量适应性随机化方法性能研究. 广州: 南方医科大学, 2020.
15. Wang T, Ma W. The impact of misclassification on covariate-adaptive randomized clinical trials. Biometrics, 2021, 77(2): 451-464.
16. Li X, Zhou J, Hu F. Testing hypotheses under adaptive randomization with continuous covariates in clinical trials. Stat Methods Med Res, 2019, 28(6): 1609-1621.
17. Zagoraiou M. Choosing a covariate-adaptive randomization procedure in practice. J Biopharm Stat, 2017, 27(5): 845-857.
18. Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther, 1974, 15(5): 443-453.
19. Baldi AA, Zagoraiou M. The covariate-adaptive biased coin design for balancing clinical trials in the presence of prognostic factors. Biometrika, 98: 519-535.
20. Qiao W, Ning J, Huang X. A clinical trial design with covariate-adjusted response-adaptive randomization using superiority confidence of treatments. Stat Biopharm Res, 2019, 11(4): 336-347.
21. Scordo MG, Pengo V, Spina E, et al. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on warfarin maintenance dose and metabolic clearance. Clin Pharmacol Ther, 2002, 72(6): 702-710.
22. Rosenberger WF, Vidyashankar AN, Agarwal DK. Covariate adjusted response adaptive designs for binary responses. J Biopharm Stat, 11: 227-236.
23. Bandyopadhyay U, Bhattacharya R. An urn based covariate adjusted response adaptive allocation design. Stat Methods Med Res, 2012, 21(2): 135-148.
24. Proschan M, Evans S. Resist the Temptation of Response-Adaptive Randomization. Clin Infect Dis, 2020, 71(11): 3002-3004.
25. Hewitt CE, Torgerson DJ. Is restricted randomisation necessary. BMJ, 2006, 332(7556): 1506-1508.

Chinese Journal of Evidence-Based Medicine

Adaptive randomization and its application in clinical trials

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