Statistical methods in clinical trials

Val J Gebski and Anthony C Keech
Med J Aust 2003; 178 (4): . || doi: 10.5694/j.1326-5377.2003.tb05139.x
Published online: 17 February 2003

Appropriate statistical methods for analysing trial data are critical for the correct interpretation of the results. Item 12 of the CONSORT statement (Box 1) relates to the statistical methods used in the reporting of trials, together with scientific and statistical principles concerning analyses of subgroups, endpoints and appropriate statistical tests. These issues need to be carefully considered before beginning a study and should be outlined in a standard trial protocol, which may be supplemented by a more extensive statistical analysis plan.1

  • Val J Gebski1
  • Anthony C Keech2

  • NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW.


Competing interests:

None identified.


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