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

Heritier, Stephane R; Gebski, Val J; Keech, Anthony C

doi:10.5694/j.1326-5377.2003.tb05627.x

Topics

Statistics, epidemiology and research design

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

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

Correspondence:

Competing interests:

None identified.

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