Statistical issues in the use of dynamic allocation methods for balancing baseline covariates

British Journal of Cancer

Volumn 104, Issue 11, 2011, Pages 1711-1715

  Pond, G R ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

balancing baseline covariates; dynamic allocation; minimisation

Indexed keywords

ARTICLE; COVARIANCE; DECISION MAKING; DYNAMIC ALLOCATION METHOD; HUMAN; PRIORITY JOURNAL; PROGNOSIS; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; STATISTICAL SIGNIFICANCE; VALIDITY;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; MEDICAL ONCOLOGY; PROGNOSIS; RANDOM ALLOCATION; RESEARCH DESIGN; STATISTICS AS TOPIC;

EID: 79957588775     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2011.157     Document Type: Article

References (42)

1. Altman DG, Bland JM (1999) Treatment allocation in controlled trials: why randomise? Br Med J 318: 1209 (Pubitemid 29201583)
2. Altman DG, Dore CJ (1990) Randomisation and baseline comparisons in clinical trials. Lancet 335: 149-153 (Pubitemid 20032736)
3. Begg CB, Iglewicz B (1990) A treatment allocation procedure for sequential clinical trials. Biometrics 36: 81-90
4. Birkett NJ (1985) Adaptive allocation in randomized control trials. Control Clin Trials 6: 146-155 (Pubitemid 15001284)
5. Brown S, Thorpe H, Hawkins K, Brown J (2005) Minimization - reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med 24: 3715-3727 (Pubitemid 43115727)
6. Buyse M, McEntegart DJ (2004a) Achieving balance in clinical trials: an unbalanced view from the European regulators. Appl Clin Trials 13(5): 36-40
7. Buyse M, McEntegart D (2004b) More nonSennse about balance in clinical trials. Appl Clin Trials 14(2): 13.7
8. Committee for Proprietary Medicinal Products (2003) Points to Consider on Adjustment for Baseline Covariates. CPMP/EWP/2863/99. Retrieved from http://www.emea.europa.eu/pdfs/human/ewp/286399en.pdf
9. Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342(25): 1887-1892 (Pubitemid 30419054)
10. Day S, Grouin J-M, Lewis JA (2005) Achieving balance in clinical trials: to say the guidance does not cite any references to support its view is an irrelevant argument. Appl Clin Trials 14(1): 24
11. Efron B (1971) Forcing a sequential experiment to be balanced. Biometrika 58(3): 403-417
12. Greenland S (1990) Randomization, statistics, and causal inference. Epidemiology 1: 421-429
13. Heritier S, Gebski V, Pillai A (2005) Dynamic balancing randomization in controlled clinical trials. Stat Med 24: 3729-3741 (Pubitemid 43115728)
14. Hofmeijer J, Anema PC, Van der Tweel I (2008) New algorithm for treatment allocation reduced selection bias and loss of power in small trials. J Clin Epidemiol 61(2): 119-124
15. Kalish LA, Begg CB (1987) The impact of treatment allocation procedures on nominal significance levels and bias. Control Clin Trials 8: 121-135 (Pubitemid 17091466)
16. Knijnenburg TA, Wessels LFA, Reinders MJT, Shmulevich I (2009) Fewer permutations, more accurate P-values. Bioinformatics 25: 161-168
17. Lachin JM (1988) Statistical properties of randomization in clinical trials. Control Clin Trials 9(4): 289-311 (Pubitemid 19012636)
18. Lee JJ, Feng L (2005) Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol 23(19): 4450-4457 (Pubitemid 46209969)
19. McEntegart DJ (2003) The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Inf J 37(3): 293-308 (Pubitemid 37309319)
20. Perry M, Faes M, Reelick MF, Olde Rikkert MG, Borm GF (2010) Studywise minimization: a treatment allocation method that improves balance among treatment groups and makes allocation unpredictable. J Clin Epidemiol 63(10): 1118-1122
21. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1976) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 34(6): 585-612 (Pubitemid 8004970)
22. Pocock SJ, Hughes MD, Lee RJ (1987) Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med 317(7): 426-432 (Pubitemid 17131180)
23. Pocock SJ, Simon R (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31: 103-115
24. Pond GR, Tang PA, Welch SA, Chen EX (2010) Trends in the application of dynamic allocation methods in multi-arm cancer clinical trials. Clin Trials 7(3): 227-234
25. Ranstam J (2009) Sampling uncertainty in medical research. Osteoarthritis Cartilage 17(11): 1416-1419
26. Roes KCB (2004) Dynamic allocation as a balancing act. Pharm Stat 3: 187-191 (Pubitemid 39654839)
27. Rosenberger WF, Lachin JM (2002) Randomisation in Clinical Trials. Theory and Practice. New York: Wiley
28. Rovers MM, Straatman H, Zielhuis GA, Ingels K, Van der Wilt GJ (2000) Using a balancing procedure in multicenter clinical trials: simulation of patient allocation based on a trial of ventilation tubes for otitis media with effusion in infants. Int J Technol AssessHealth Care 16: 276-280
29. Schulz KF, Altman DG, Moher D, for the CONSORT Group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8: 18
30. Senn SJ (2000) Consensus and controversy in pharmaceutical statistics (with discussion). Statistician 49: 135-176
31. Senn SJ (2004) Unbalanced claims for balance. Appl Clin Trials 13(6): 14-15
32. Senn S, Anisimov VV, Fedorov VV (2010) Comparisons of minimization and Atkinson's algorithm. Stat Med 29: 721-730
33. Simon R (1979) Restricted randomization designs in clinical trials. Biometrics 35: 503-512 (Pubitemid 9208272)
34. Taves DR (1974) Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther 15: 443-453
35. Taves DR (2004) Faulty assumptions in Atkinson's criteria for clinical trial design. J R Stat Soc Series A 167(1): 179-180
36. Therneau TM (1993) How many stratification factors are 'too many' to use in a randomization plan? Control Clin Trials 14: 98-108 (Pubitemid 23102299)
37. Treasure T, MacRae K (1998) Minimisation: the platinum standard for trials? (Randomisation doesn't guarantee similarity of groups; minimisation does). Br Med J 317(5): 362-363
38. Tu D, Shalay K, Pater J (2000) Adjustments of treatment effect for covariates in clinical trials: statistical and regulatory issues. Drug Inf J 34: 511-523 (Pubitemid 30351004)
39. Wei L-J (1977) A class of designs for sequential clinical trials. J Am Stat Assoc 72(358): 382-386
40. Zelen M (1969) Play the winner rule and the controlled clinical trial. J Am Stat Assoc 64: 131-146
41. Zelen M (1974) The randomization and stratification of patients to clinical trials. J Chronic Dis 27: 365-375
42. Zhou X, Liu S, Kim ES, Herbst RS, Lee JJ (2008) Bayesian adaptive design for targeted therapy development in lung cancer - a step toward personalized medicine. Clin Trials 5: 181-193