Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence

Contemporary Clinical Trials

Volumn 27, Issue 5, 2006, Pages 420-431

  Endo, Akira ^a,c   Nagatani, Fumio ^b   Hamada, Chikuma ^c   Yoshimura, Isao ^c  

^a Development and Medical Affairs Division   (Japan)

^b AJINOMOTO CO INC   (Japan)

^c TOKYO UNIVERSITY OF SCIENCE   (Japan)

Author keywords

Continuous prognostic variable; Diabetes mellitus; Hyperlipidemia; Kullback Leibler divergence; Minimization method; Two armed trial

Indexed keywords

ACCURACY; ARTICLE; COVARIANCE; HYPERLIPIDEMIA; HYPOTHESIS; INTERMETHOD COMPARISON; KULLBACK LEIBLER DIVERGENCE; MATHEMATICAL ANALYSIS; MATHEMATICAL PARAMETERS; POCOCK SIMON METHOD; PROBABILITY; PROGNOSIS; SEQUENTIAL ANALYSIS; SIMULATION;

CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; CONFIDENCE INTERVALS; CONTROLLED CLINICAL TRIALS; CONTROLLED CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS; HUMANS; MATHEMATICS; MODELS, STATISTICAL; PATIENT SELECTION; PROGNOSIS; RESEARCH DESIGN; STATISTICAL DISTRIBUTIONS;

EID: 33746931274     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.2320/jinstmet.70.420     Document Type: Article

References (16)

1. Rosenberger W.F., and Lachin J.M. Randomization in clinical trials (2002), John Wiley & Sons, Inc., New York
2. Taves D.R. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther 15 (1974) 443-453
3. Pocock S.J., and Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31 (1975) 103-115
4. Piantadosi S. Clinical trials (1997), John Wiley & Sons, Inc., New York
5. Hagino A., Hamada C., Yoshimura I., et al. Statistical comparison of random allocation methods in cancer clinical trials. Control Clin Trials 25 (2004) 572-584
6. Committee for Proprietary Medicinal Products. Point to consider on adjustment for baseline covariates (CPMP/EWP/2863/99) (2003), EMEA, London
7. ICH E9 Expert Working Group. Statistical principles for clinical trials. Stat Med 18 (1999) 1905-1942
8. Roes K.C.B. Regulatory perspectives: dynamic allocation as a balancing act. Pharm Stat 3 (2004) 187-191
9. Scott N.W., McPherson G.C., Ramsay C.R., and Campbell M.K. The method of minimization for allocation to clinical trials: a review. Control Clin Trials 23 (2002) 662-674
10. McEntegart D.J. The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Inf J 37 (2003) 293-308
11. Efron B. Forcing a sequential experiment to be balanced. Biometrika 58 (1971) 403-417
12. Nishi T., and Takaichi A. An extended minimization method to assure similar means of continuous prognostic variables between treatment groups. Jpn J Biom 24 (2003) 43-55
13. Dragalin V., Fedorov V., Patterson S., and Jones B. Kullback-Leibler divergence for evaluating bioequivalence. Stat Med 22 (2003) 913-930
14. Kullback S. Information theory and statistics (1959), John Wiley & Sons, Inc., New York
15. McEntegart D.J. Letter to editor. Stat Med 23 (2004) 3719-3720
16. Hamada C., Honda Y., Murakami Y., and Niimi M. Evaluation for the long-term efficacy and safety of Pravastatin for the patients with hypercholesterolemia and diabetes mellitus using meta-analysis. Prog Med 16 (1996) 1424-1430 [in Japanese]