Analysis of the application of randomization methods in clinical trials in <i>NEJM</i>_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Yaqi ^1,2 , LIU Man ^1,2 ,  LIU Yuxiu ^1,2,3 , CHEN Wensong ^1,2 , YUAN Yangdan ^2,3

1. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, P.R.China;
2. Department of Critical Care Medicine, General Hospital of Eastern Theater Command, Nanjing 210002, P.R.China;
3. Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou 510515, P.R.China;

Corresponding?author：

LIU Yuxiu, Email: liu_yuxiu@163.com

Keywords：

Randomized controlled trial; Randomization; Allocation concealment; Selection bias; NEJM

DOI：

10.7507/1672-2531.202010080

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To analyze the current status of the application of randomization methods in randomized controlled trials (RCTs) which have been published in New England Journal of Medicine (NEJM).Methods RCTs published by NEJM in 2018 were searched and collected. The characteristics of clinical trial design elements and the application status of randomization methods were comprehensively analyzed to distinguish blind trial and non-blind trial, and characteristics of application of randomization methods and selection of allocation concealment mechanisms of non-blind trials were summarized.Results A total of 151 RCTs were published in NEJM in 2018, in which blinded trials and non-blinded trials accounted for 75 (49.67%) and 76 (50.33%), respectively. 34 (22.52%) RCTs did not report specific randomization methods, and the remaining 117 (77.48%) reported. Among the latter, stratified block randomization accounted for the main body (72.65%), followed by block randomization (11.11%), minimization method (9.40%), simple randomization method (4.27%) and the others. There was no significant difference in the proportion of reporting or using randomization methods between blind and non-blind trials (P>0.05). In 76 non-blind trials, 38 (50.00%) clearly reported the concealment method of random allocation, among which 37 used the central randomization (97.37%) and 1 used envelope method (2.63%).Conclusions The current RCTs published in NEJM still have problems in the selection of randomization methods to be optimized and the transparency of randomization reporting to be improved.

Citation： LIU Yaqi, LIU Man, LIU Yuxiu, CHEN Wensong, YUAN Yangdan. Analysis of the application of randomization methods in clinical trials in NEJM. Chinese Journal of Evidence-Based Medicine, 2021, 21(3): 303-307. doi: 10.7507/1672-2531.202010080 Copy

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2.	呂燃, 陳能, 劉少南, 等. 單髁置換術治療膝骨關節炎對術后人工關節遺忘程度影響的Meta分析. 中國循證醫學雜志, 2020, 20(8): 956-961.
3.	尤壽江, 仲崇科, 毛學宇, 等. 蚓激酶膠囊治療急性缺血性卒中有效性和安全性的Meta分析. 中國循證醫學雜志, 2020, 20(7): 829-836.
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6.	Rosenberger WF, Lachin JM. Randomization in clinical trials: theory and practice, second edition. New Jersey: John Wiley & Sons, 2016.
7.	Clark L, Schmidt U, Tharmanathan P, et al. Poor reporting quality of key randomization and allocation concealment details is still prevalent among published RCTs in 2011: a review. J Eval Clin Pract, 2013, 19(4): 703-707.
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9.	Lin Y, Zhu M, Su Z. The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials. Contemp Clin Trials, 2015, 45(Pt A): 21-25.
10.	陳君超, 何迎春, 陳歡, 等. 隨機化方法與技術在當前臨床試驗中的應用. 中國新藥雜志, 2019, 28(13): 1582-1586.
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14.	Berger VW. Do not use blocked randomization. Headache, 2006, 46(2): 343.
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16.	Zhao W. A better alternative to the inferior permuted block design is not necessarily complex. Stat Med, 2016, 35(10): 1736-1738.
17.	袁陽丹, 劉甜甜, 劉玉秀, 等. 臨床試驗隨機化方法的優選. 中國衛生統計, 2019, 36(2): 204-208.
18.	Zhao WL, Weng Y. Block urn design-a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation. Contemp Clin Trials, 2011, 32(6): 953-961.

1. Cartwright N. Are RCTs the gold standard? BioSocieties, 2007, 2(1): 11-20.
2. 呂燃, 陳能, 劉少南, 等. 單髁置換術治療膝骨關節炎對術后人工關節遺忘程度影響的Meta分析. 中國循證醫學雜志, 2020, 20(8): 956-961.
3. 尤壽江, 仲崇科, 毛學宇, 等. 蚓激酶膠囊治療急性缺血性卒中有效性和安全性的Meta分析. 中國循證醫學雜志, 2020, 20(7): 829-836.
4. Michael NL. Clinical trial design: the nobility of randomization. Sci Transl Med, 2017, 9(419): 0810-0811.
5. 劉玉秀. 臨床試驗隨機化要領. 醫學研究生學報, 2015, 28(2): 113-117.
6. Rosenberger WF, Lachin JM. Randomization in clinical trials: theory and practice, second edition. New Jersey: John Wiley & Sons, 2016.
7. Clark L, Schmidt U, Tharmanathan P, et al. Poor reporting quality of key randomization and allocation concealment details is still prevalent among published RCTs in 2011: a review. J Eval Clin Pract, 2013, 19(4): 703-707.
8. Higham R, Tharmanathan P, Birks Y. Use and reporting of restricted randomization: a review. J Eval Clin Pract, 2015, 21(6): 1205-1211.
9. Lin Y, Zhu M, Su Z. The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials. Contemp Clin Trials, 2015, 45(Pt A): 21-25.
10. 陳君超, 何迎春, 陳歡, 等. 隨機化方法與技術在當前臨床試驗中的應用. 中國新藥雜志, 2019, 28(13): 1582-1586.
11. Emerson JD, Colditz GA. Use of statistical analysis in the New England Journal of Medicine. N Engl J Med, 1983, 309(12): 709-713.
12. Horton NJ, Switzer SS. Statistical methods in the journal. N Engl J Med, 2005, 353(18): 1977-1979.
13. Sato Y, Gosho M, Nagashima K, et al. Statistical methods in the journal - an update. N Engl J Med, 2017, 376(11): 1086-1087.
14. Berger VW. Do not use blocked randomization. Headache, 2006, 46(2): 343.
15. Berger VW. Misguided precedent is not a reason to use permuted blocks. Headache, 2006, 46(7): 1210-1212.
16. Zhao W. A better alternative to the inferior permuted block design is not necessarily complex. Stat Med, 2016, 35(10): 1736-1738.
17. 袁陽丹, 劉甜甜, 劉玉秀, 等. 臨床試驗隨機化方法的優選. 中國衛生統計, 2019, 36(2): 204-208.
18. Zhao WL, Weng Y. Block urn design-a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation. Contemp Clin Trials, 2011, 32(6): 953-961.

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