Dynamic allocation as a balancing act

Pharmaceutical Statistics

Volumn 3, Issue 3, 2004, Pages 187-191

  Roes, Kit C B ^a  

^a NV Organon ^*  (Netherlands)

Author keywords

Clinical trials; Dynamic allocation; Randomization

Indexed keywords

DRUG;

COST EFFECTIVENESS ANALYSIS; DRUG RESEARCH; EXPERIMENTAL DESIGN; MATHEMATICAL ANALYSIS; PREDICTION; PROGNOSIS; RANDOMIZATION; REVIEW; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW;

EID: 10644289282     PISSN: 15391604     EISSN: None     Source Type: Journal    
DOI: 10.1002/pst.118     Document Type: Review

References (12)

1. Philips A, Ebbutt A, France L, Morgan D, Ireson M, Struthers L, Heimann G. Issues in applying recent CPMP 'Points to Consider' and FDA guidance documents with biostatistical implications. Pharmaceutical Statistics 2003; 2:241-251.
2. ICH E9, Statistical Principles for Clinical Trials, consensus guideline, 5 September 1998. Available at http://www.fda.gov/cder/guidance/index.htm.
3. CPMP. Points to consider on adjustment for baseline covariates. EMEA: London, 2003. Available at http://www.emea.int/htms/human/ewp/ewpptc.htm.
4. PSI website. Discussion forums: Dynamic allocation of treatments. March 2002-October 2003. http://www.psiweb.org/forums.
5. McEntegart DJ. The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Information Journal 2002; 37:293-308.
6. Scott NW, McPherson GC, Ramsay CR, Campbell MK. The method of minimization for allocation to clinical trials: a review. Controlled Clinical Trials 2002; 23:662-674.
7. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-115.
8. Lehmann EL. Testing statistical hypotheses, 2nd edition. John Wiley & Sons: New York, 1986.
9. Treasure T, MacRae KD. Minimisation: the platinum standard for trials? Randomisation doesn't guarantee similarity of groups; minimisation does. British Medical Journal 1998; 317:362-363.
10. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359 614-618.
11. van der Meulen EA. Are we really that blind? Journal of Biopharmaceutical Statistics (submitted).
12. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Statistics in Medicine 2002; 21:2917-2930.