Specifying objectives and outcomes for clinical trials

Val J Gebski, Ian Marschner and Anthony C Keech
Med J Aust 2002; 176 (10): . || doi: 10.5694/j.1326-5377.2002.tb04522.x
Published online: 20 May 2002

Thorough definitions and descriptions of the objectives and outcomes in clinical trials lead to results that are more readily interpretable and more easily generalisable. Indeed, the failure to prospectively define both objectives and outcomes in sufficient detail, and to describe how these are to be measured, has been a major criticism of some randomised trials.1 Items 5 and 6 of the CONSORT statement checklist relate to objectives and outcomes in randomised trials.2

  • Val J Gebski1
  • Ian Marschner2
  • Anthony C Keech3

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



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