Quantification of predictability in clinical trials using block randomization

Drug Information Journal

Volumn 38, Issue 2, 2004, Pages 127-133

  Dupin Spriet, Thérèse ^a   Fermanian, Jacques ^b   Spriet, Alain ^c  

^a UNIV LILLE   (France)

^b HÔPITAL NECKER ENFANTS MALADES   (France)

^c Alain Spriet Conseil   (France)

Author keywords

Block randomization; Clinical trials; Concealment; Predictability; Selection bias

Indexed keywords

ARTICLE; HUMAN; MATHEMATICAL COMPUTING; MEDICAL RESEARCH; METHODOLOGY; PRIORITY JOURNAL;

EID: 4544258476     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150403800205     Document Type: Article

References (19)

1. Matts JP, Lachin JM. Properties of permuted-block randomization in clinical trials. Control Clin Trials. 1988;9:327-344.
2. Chalmers TC, Celano P, Sacks HS, Smith, H. Bias in treatment assignment in controlled clinical trials. New Engl J Med. 1983;309:1358-1361.
3. Kunz R, Oxman AO. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. Br Med J. 1998;317:1185-1190.
4. Moher D, Ba'Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-613.
5. Schulz KF, Chalmers I, Hayes RJ, Altman, DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-412.
6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Note for Guidance on Statistical Principles for Clinical Trials. CPMP/ICH/ 363/97 1998,43. Geneva, Switzerland: International Conference on Harmonisation; 1998.
7. Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990;335:149-153.
8. Williams DH, Davis CE. Reporting of assignment methods in clinical trials. Control Clin Trials. 1994;15:294-298.
9. Schulz VF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994;272:125-128.
10. Schulz KF. Subverting randomisation in controlled trials. JAMA. 1995;274:1456-1458.
11. Peto R. Failure of randomisation by "sealed" envelope. Lancet. 1999;354:73.
12. Senn S. "Allocating Treatments to Patients in Clinical Trials." In Statistical Issues In Drug Development. Chichester, England: John Wiley and Sons; 1997.
13. Kunselman SJ, Armstrong TJ, Britton TB, Forand PE, for the Asthma Clinical Research Network. Implementing randomization procedures in the Asthma Clinical Research Network. Control Clin Trials. 2001;22:181S-195S.
14. Efron B. Forcing a sequential experiment to be balanced. Biometrika. 1971;58:403-417.
15. Zelen M. The randomization and stratification of patients to clinical trials. J Chron Dis. 1974;27:365-375.
16. Klotz JH. Maximum entropy constrained balance randomization for clinical trials. Biometrics. 1978;34:283-287.
17. Titterington DM. On constraining balance randomisation for clinical trials. Biometrics 1983;39:1083-1086.
18. Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet. 2002;359(9310):966-970.
19. nd Ed. Chichester, England: John Wiley and Sons; 1957; Vol. 1.