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Randomisation in clinical trials

Elaine M Beller, Val Gebski and Anthony C Keech
Med J Aust 2002; 177 (10): . || doi: 10.5694/j.1326-5377.2002.tb04955.x
Published online: 18 November 2002

Randomisation is the process of assigning clinical trial participants to treatment groups. Randomisation gives each participant a known (usually equal) chance of being assigned to any of the groups. Successful randomisation requires that group assignment cannot be predicted in advance.


  • 1 Queensland Clinical Trials Centre, University of Queensland, Herston, QLD.
  • 2 NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW.


Correspondence: enquiry@ctc.usyd.edu.au

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  • 2. Keech A. Random allocation. Introduction to clinical trials. Clinical trials research methodology. Statistical methods in clinical trials. The ICH GCP guidelines. Hong Kong: The Clinical Trials Centre, 1998.
  • 3. Pocock S. Clinical trials. A practical approach. New York: John Wiley, 1984.
  • 4. 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.
  • 5. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998; 352: 609-613.
  • 6. Gebski V, Beller E, Keech AC. Randomised trials: elements of a good study. Med J Aust 2001; 175: 272-274.

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