R language implementation of response-adaptive randomization_Chinese Journal of Evidence-Based Medicine

Authors：

SHUAI Yuxing ¹ , ZHOU Sha ² , CHEN Zhuoqun ³ , ZHU Ke ³ , XU Qian ¹ , WANG Liangjing ³ , MA Huilin ¹ , SHAN Zejun ¹ , XU Yingjian ¹ , DU Liang ⁴ ,  CHEN Xinlin ¹

1. School of Basic Medicine, Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;
2. Second Clinical School, Guangzhou University of Chinese Medicine, Guangzhou 510403, P. R. China;
3. Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;
4. West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

CHEN Xinlin, Email: chenxlsums@126.com

Keywords：

Response-adaptive randomization; R language; Random allocation; Clinical trials

DOI：

10.7507/1672-2531.202409080

Video：

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Response-adaptive randomization (RAR) dynamically adjusts the probability of assigning patients to different groups, optimizing treatment efficacy and participant welfare. It is particularly suitable for clinical studies involving multiple interventions or dose-finding and seamless phase II/III trials. This paper systematically introduces the concept, principles, and types of RAR, as well as its application in clinical trials (including traditional Chinese medicine research). It also provides R implementation code, offering researchers practical tools aimed at promoting the adoption of RAR in clinical practice.

1.	Ciolino JD, Palac HL, Yang A, et al. Ideal vs. real: a systematic review on handling covariates in randomized controlled trials. BMC Med Res Methodol, 2019, 19(1): 136.
2.	Kairalla JA, Coffey CS, Thomann MA, et al. Adaptive trial designs: a review of barriers and opportunities. Trials, 2012, 13: 145.
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6.	Maslove DM, Lamontagne F, Marshall JC, et al. A path to precision in the ICU. Crit Care, 2017, 21(1): 79.
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8.	Villar SS, Wason J, Bowden J. Response-adaptive randomization for multi-arm clinical trials using the forward looking Gittins index rule. Biometrics, 2015, 71(4): 969-978.
9.	Zhu H, Piao J, Lee JJ, et al. Response adaptive randomization procedures in seamless phase II/III clinical trials. J Biopharm Stat, 2020, 30(1): 3-17.
10.	Robertson DS, Lee KM, López-Kolkovska BC, et al. Response-adaptive randomization in clinical trials: from myths to practical considerations. Stat Sci, 2023, 38(2): 185-208.
11.	Hu F, Rosenberger WF. The theory of response-adaptive randomization in clinical trials. Wiley Series in Probability and Statistics. 2006.
12.	Lin J, Lin L, Bunn V, et al. Adaptive randomization for master protocols in precision medicine. In: Contemporary biostatistics with biopharmaceutical applications. Cham: Springer International Publishing, 2019: 251-270.
13.	钱真真, 周莎, 于亚南, 等. 适应性随机化及其在临床试验中的应用操作要点. 中国循证医学杂志, 2022, 22(8): 971-977.
14.	金秋百, 张颖, 姜枫, 等. 反应适应性随机的实施要点及其在中医药临床研究中的应用前景. 中医杂志, 2021, 62(17): 1478-1483.
15.	Proschan M, Evans S. Resist the temptation of response-adaptive randomization. Clin Infect Dis, 2020, 71(11): 3002-3004.
16.	Hu C, Yan Z, Jiang J, et al. Traditional chinese medicine information analysis based on multi-task joint learning model. In: Lecture Notes in Bioinformatics. Singapore: Springer Nature Singapore, 2022.
17.	Zhang J, Saju C. A systematic review of randomised controlled trials with adaptive and traditional group sequential designs - applications in cardiovascular clinical trials. BMC Med Res Methodol, 2023, 23(1): 200.
18.	高颖. 中医辨证治疗非糜烂性胃食管反流病46例临床观察. 实用中西医结合临床, 2010, 10(6): 25-26.

1. Ciolino JD, Palac HL, Yang A, et al. Ideal vs. real: a systematic review on handling covariates in randomized controlled trials. BMC Med Res Methodol, 2019, 19(1): 136.
2. Kairalla JA, Coffey CS, Thomann MA, et al. Adaptive trial designs: a review of barriers and opportunities. Trials, 2012, 13: 145.
3. Marchenko O, Nolan C. Implementing adaptive designs: operational considerations, putting it all together. In: Practical considerations for adaptive trial design and implementation. New York: Springer New York, 2014: 203-223.
4. Wang Y, Carter BZ, Li Z, et al. Application of machine learning methods in clinical trials for precision medicine. JAMIA Open, 2022, 5(1): ooab107.
5. Garczarek U, Muehlemann N, Richard F, et al. Bayesian Strategies in Rare Diseases. Ther Innov Regul Sci, 2023, 57(3): 445-452.
6. Maslove DM, Lamontagne F, Marshall JC, et al. A path to precision in the ICU. Crit Care, 2017, 21(1): 79.
7. Davey RT Jr, Dodd LE, Proschan M, et al. A randomized, controlled trial of zmapp for ebola virus infection. N Engl J Med. 2016, 375(15): 1448-1456.
8. Villar SS, Wason J, Bowden J. Response-adaptive randomization for multi-arm clinical trials using the forward looking Gittins index rule. Biometrics, 2015, 71(4): 969-978.
9. Zhu H, Piao J, Lee JJ, et al. Response adaptive randomization procedures in seamless phase II/III clinical trials. J Biopharm Stat, 2020, 30(1): 3-17.
10. Robertson DS, Lee KM, López-Kolkovska BC, et al. Response-adaptive randomization in clinical trials: from myths to practical considerations. Stat Sci, 2023, 38(2): 185-208.
11. Hu F, Rosenberger WF. The theory of response-adaptive randomization in clinical trials. Wiley Series in Probability and Statistics. 2006.
12. Lin J, Lin L, Bunn V, et al. Adaptive randomization for master protocols in precision medicine. In: Contemporary biostatistics with biopharmaceutical applications. Cham: Springer International Publishing, 2019: 251-270.
13. 钱真真, 周莎, 于亚南, 等. 适应性随机化及其在临床试验中的应用操作要点. 中国循证医学杂志, 2022, 22(8): 971-977.
14. 金秋百, 张颖, 姜枫, 等. 反应适应性随机的实施要点及其在中医药临床研究中的应用前景. 中医杂志, 2021, 62(17): 1478-1483.
15. Proschan M, Evans S. Resist the temptation of response-adaptive randomization. Clin Infect Dis, 2020, 71(11): 3002-3004.
16. Hu C, Yan Z, Jiang J, et al. Traditional chinese medicine information analysis based on multi-task joint learning model. In: Lecture Notes in Bioinformatics. Singapore: Springer Nature Singapore, 2022.
17. Zhang J, Saju C. A systematic review of randomised controlled trials with adaptive and traditional group sequential designs - applications in cardiovascular clinical trials. BMC Med Res Methodol, 2023, 23(1): 200.
18. 高颖. 中医辨证治疗非糜烂性胃食管反流病46例临床观察. 实用中西医结合临床, 2010, 10(6): 25-26.

Chinese Journal of Evidence-Based Medicine

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