Inclusion of patients in clinical trial analysis: the intention-to-treat principle

Stephane R Heritier, Val J Gebski and Anthony C Keech
Med J Aust 2003; 179 (8): . || doi: 10.5694/j.1326-5377.2003.tb05627.x
Published online: 20 October 2003

Determining the sample of participants to be analysed is a crucial step in reporting clinical trials. For such analyses, the gold standard is the “intention-to-treat” principle. The question of which participants are included in the analysis appears as Item 16 of the CONSORT statement (Box 1).1

  • Stephane R Heritier1
  • Val J Gebski2
  • Anthony C Keech3

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


Competing interests:

None identified.


remove_circle_outline Delete Author
add_circle_outline Add Author

Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Online responses are no longer available. Please refer to our instructions for authors page for more information.