Expansion of the modified Zelen's approach randomization and dynamic randomization with partial block supplies at the centers to unequal allocation

Contemporary Clinical Trials

Volumn 32, Issue 6, 2011, Pages 962-972

  Kuznetsova, O M ^a   Tymofyeyev, Y ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Allocation ratio; Modified Zelen's approach; Multi center study; Multi regional study; Partial block supplies; Randomization; Unequal allocation

Indexed keywords

ARTICLE; HUMAN; INTERMETHOD COMPARISON; METHODOLOGY; MODIFIED ZELEN APPROACH; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESOURCE ALLOCATION; TREATMENT PLANNING;

CLINICAL PROTOCOLS; HUMANS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 80053384605     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2011.08.006     Document Type: Article

References (34)

1. Morrissey M., McEntegart D., Lang M. Randomisation in double-blind multicentre trials with many treatments. Contemp. Clin. Trials 2010, 31:381-391. 10.1016/j.cct.2010.05.002.
2. Therneau T.M. How many stratification factors are "too many" to use in a randomization plan?. Control. Clin. Trials 1993, 14(2):98-108.
3. Kuznetsova O., Ivanova A. Allocation in randomized clinical trials. Pharmaceutical statistics using SAS 2006, SAS Press, Cary, NC. A. Dmitrienko, C. Chuang-Stein, R. D'Agostino (Eds.).
4. Kuznetsova O.M. Randomization schedule. Wiley encyclopedia of clinical trials 2008, John Wiley &Sons., Inc, Hoboken. 10.1002/9780471462422.eoct314. R. D'Agostino, L. Sullivan, J. Massaro (Eds.).
5. Song C., Kuznetsova O.M. Implementing constrained or balanced across the centers randomization with SAS v8 procedure plan. PharmaSUG 2003 proceedings 2003, 473-479.
6. Zelen M. The randomization and stratification of patients to clinical trials. J. Chron. Dis. 1974, 27:365-375.
7. McEntegart D. Blocked Randomization. Wiley encyclopedia of clinical trials June 13 2008, John Wiley &Sons., Inc, Hoboken. 10.1002/9780471462422.eoct301. R. D'Agostino, L. Sullivan, J. Massaro (Eds.).
8. Dumville J.C., Hahn S., Miles J.N.V., Torgerson D.J. The use of unequal randomisation ratios in clinical trials: a review. Contemp. Clin. Trials 2006, 27:1-12. 10.1016/j.cct.2005.08.003.
9. McEntegart D., Dawson R. Letter to the Editor re Dumville et al. Contemp. Clin. Trials 2006, 27:207-208. 10.1016/j.cct.2006.02.003.
10. Kuznetsova O, Tymofyeyev Y. Brick Tunnel Randomization - a Way to Accommodate a Problematic Allocation Ratio in Adaptive Design Dose Finding Studies. ASA Proceedings of the Joint Statistical Meetings, 1356-1367. American Statistical Association (Alexandria, VA).
11. Kuznetsova O., Tymofyeyev Y. Brick tunnel randomization for unequal allocation to two or more treatment groups. Stat. Med. 2011, 30:812-824. 10.1002/sim.4167.
12. Kuznetsova O.M., Tymofyeyev Y. Preserving the allocation ratio at every allocation with biased coin randomization and minimization in studies with unequal allocation 2011, (submitted to Statist. Med February 2011).
13. Proschan M., Brittain E., Kammerman L. Minimize the use of minimization with unequal allocation. Biometrics 2011, 10.1111/j.1541-0420.2010.01545.x.
14. McEntegart D. Forced randomization when using interactive voice response systems. Appl. Clin. Trials August 2002, 2-10.
15. Berger V.W., Ivanova A., Knoll M. Minimizing predictability while retaining balance trough the use of less restrictive randomization procedures. Stat. Med. 2003, 22:3017-3028. 10.1002/sim.1538.
16. Salama I., Ivanova A., Qaqish B. Efficient generation of constrained block allocation sequences. Stat. Med. 2008, 27:1421-1428. 10.1002/sim3014.
17. Signorini D.F., Leung O., Simes R.J., Beller E., Gebski V.J. Dynamic balanced randomisation for clinical trials. Stat. Med. 1993, 12:2343-2350.
18. Heritier S., Gebski V., Pillai A. Dynamic balancing randomization in controlled clinical trials. Stat. Med. 2005, 24:3729-3741. 10.1002/sim.2421.
19. Taves D. Minimization: a new method of assigning subjects to treatment and control groups. Clin. Pharmacol. Ther. 1974, 15:443-453.
20. Pocock S.J., Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31:103-115.
21. McEntegart D. The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Inf. J. 2003, 37:293-308.
22. Scott N.W., McPherson G.C., Ramsay C.R., Campbell M.K. The method of minimization for allocation to clinical trials: a review. Control. Clin. Trials 2002, 23:662-674.
23. Frane J.W. A method of biased coin randomization, its implementation, and its validation. Drug Inf. J. 1998, 32:423-432. DOI:0092-8615/98.
24. Rosenberger W.F., Lachin J.M. Randomization in clinical trials 2002, John Wiley & Sons, New York.
25. Nishi T., Takaishi A. An extended minimization method to assure similar means of continuous prognostic variable between treatment groups. Jpn J. Biometrics 2003, 24:43-55.
26. Akazawa K., Odaka T., Sakamoto M., Ohtsuki S., Shimada M., Kamakura T., Nose Y. A Random Allocation System with the Minimization Method for Multi-Institutional Clinical Trials. Journal of Medical Systems 1991, 15:311-319.
27. Kuznetsova OM, Tymofyeyev Y. Dynamic Allocation Procedures Based on Modified Zelen's Approach in Multi-Regional Studies With Unequal Allocation (Submitted to Contemp Clin Trials July 2011).
28. Kuznetsova O.M. 'Why permutation is even more important in IVRS drug codes schedule generation than in patient randomisation schedule generation. Letter to the Editor. Control. Clin. Trials 2001, 22(1):69-71.
29. Lang M, Wood R, and McEntegart D. Protecting the blind GCPj November 05 14/11/05 3:39 pm Page 10.
30. Byrom B., McEntegart D. Adaptive infrastructure. Adaptive designs in pharmaceutical/clinical development October 2010, Chapman & Hall/CRC, Taylor and Francis. C. Shein-Chung (Ed.).
31. Waters S., McEntegart D., et al. Enhancing control of the medication supply chain in clinical trials managed by interactive voice response systems. Drug Inf. J. November 2010, 727-740.
32. Rosenberger W.F., Sverdlov O. Handling covariates in the design of clinical trials. Stat. Sci. 2008, 23:404-419.
33. Downs M., Tucker K., Christ-Schmidt H., Wittes J. Some practical problems in implementing randomization. Clin. Trials 2010, 7:235-245.
34. He, W. et al. Practical Considerations for Adaptive Design Trial Implementations. In submission to DIJ.