A better alternative to stratified permuted block design for subject randomization in clinical trials

Statistics in Medicine

Volumn 33, Issue 30, 2014, Pages 5239-5248

  Zhao, Wenle ^a  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Biased coin minimization method; Big stick design; Block urn design; Clinical trial; Permuted block; Randomization

Indexed keywords

ALGORITHM; ARTICLE; BIG STICK DESIGN; BLOCK URN DESIGN; COVARIANCE; PROBABILITY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIMULATION; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS; STRATIFICATION; STRATIFIED PERMUTED BLOCK RANDOMIZATION; TWO STAGE COVARIATE ADAPTIVE RANDOMIZATION; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; HUMAN; METHODOLOGY; PROBABILITY THEORY; PROCEDURES; STATISTICAL BIAS;

ALGORITHMS; BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; HUMANS; PROBABILITY; PROBABILITY THEORY; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84918820274     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6266     Document Type: Article

References (35)

1. Armitage P. The role of randomization in clinical trials. Statistics in Medicine 1982; 1:345-352.
2. Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials 3rdEdition. Springer Science: New York, 1988.
3. Rosenberger WF, Lachin JM. Randomization in Clinical Trials Theory and Practice. Wiley- Interscience: New York, 2002.
4. Lachin JM. Properties of simple randomization in clinical trials. Controlled Clinical Trials 1988; 9:312-326.
5. Zelen M. The randomization and stratification of patients to clinical trials. Journal of Chronic Disease 1974; 28:365-375.
6. McEntegart DJ. The pursuit of balance using stratified and dynamic ran- domization techniques: an overview. Drug Information Journal 2003; 37:293-308.
7. Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clinical Pharmacology and Therapeutics 1974; 15:443-453.
8. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31:103-115.
9. Begg CB, Iglewicz B. A treatment allocation procedure for sequential clinical trials. Biometrics 1980; 36:81-90.
10. Atkinson AC. Optimal biased coin designs for sequential clinical trials with prognostic factors. Biometrika 1982; 69:61-67.
11. Berger VW. Minimization, by its nature, precludes allocation concealment, and invites selection bias. Contemporary Clinical Trials 2010; 31:5;406.
12. Taves DR. The use of minimization in clinical trials. Contemporary Clinical Trials 2010; 31(2):180-184.
13. Matts JP, Lachin JM. Control. Properties of permuted-block randomization in clinical trials. Clinical Trials 1988; 9:327-344.
14. ICH Harmonized Tripartite Guideline E9: Statistical Principals for Clinical Trials, 5 February 1998.
15. Zhao W, Weng Y, Wu Q, Palesch Y. Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness. Pharmaceutical Statistics 2012; 11:39-48.
16. Berger VW. Do not use blocked randomization. Headache 2006a; 46(2):343.
17. Berger VW. Misguided precedent is not a reason to use permuted blocks. Headache 2006b; 46(7):1210-1212.
18. Berger VW. Varying block sizes does not conceal the allocation. Journal of Critical Care 2006c; 21(2):229.
19. Zhao W. Selection bias, allocation concealment and randomization design in clinical trials. Contemporary Clinical Trials 2013; 36:263-265.
20. Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. Journal of Clinical Epidemiology 1999; 521:19-26.
21. Hill AB. The clinical trial. British Medical Bulletin 1951; 71:278-282.
22. Blackwell D, Hodges JL. Design for the control of selection bias. Annals of Mathematical Statistics 1957; 28:449-460.
23. Berger VW, Ivanova A, Deloria-Knoll M. Minimizing Predictability while retaining balance through the use of less restrictive randomization procedures. Statistics in Medicine 2003; 22:3017-3028.
24. Efron B. Forcing a sequential experiment to be balanced. Biometrika 1971; 58:403-417.
25. Wei LJ. A class of designs for sequential clinical trials. Journal of the American Statistical Association 1977; 72:382-386.
26. Smith RL. Sequential treatment allocation using biased coin designs. Journal of the Royal Statistical Society Series B (Methodological) 1984; 46:519-543.
27. Soares JF, Wu CF. Some restricted randomization rules in sequential designs. Communications in Statistics - Theory and Methods 1983; 12:2017-2034.
28. Zhao W, Weng Y. Block urn design - a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation. Contemporary Clinical Trials 2012; 32:953-961.
29. Zhao W, Weng Y. A simplified formula for quantification of the probability of deterministic assignment in permuted block randomization. Journal of Statistical Planning and Inference 2011; 141(1):474-478.
30. Kundt G. A new proposal for setting parameter values in restricted randomization methods. Methods of Information in Medicine 2007 46:440-449.
31. Chen YP. Which design is better? Ehrenfest yrn versus biased coin. Advances in Applied Probability 2000; 32:738-749.
32. Salama I, Ivanova A, Qaqish B. Efficient generation of constrained block allocation sequences. Statistics in Medicine 2008; 27(9): 1421-1428.
33. Chen YP. Biased coin design with imbalance tolerance. Communications in Statistics, Stochastic Models 1999; 15:953-975.
34. Efron B. Randomizing and balancing a complicated sequential experiment. in Biostatistics Casebook. Miller RG, Efron B, Brown BW, Moses LE, (eds). Wiley: New York, 1980; 19-30.
35. Berger VW. Selection Bias And Covariate Imbalances In Randomized Clinical Trials. John Wiley & Sons: Chichester, Sussex, UK, 2005.