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In reply: Determining the sample size in a clinical trial

Adrienne Kirby, Val Gebski and Anthony C Keech
Med J Aust 2003; 178 (7): 358.
Published online: 7 April 2003

In reply: A key message of our article is that the minimum possible difference that would render the intervention clinically worthwhile needs to be determined in the design phase of the study.1 This potential clinical difference (net advantage over standard care) must, of necessity, incorporate the potential trade-offs between any outcome advantages and associated toxicities and/or cost disadvantages.

  • Adrienne Kirby
  • Val Gebski
  • Anthony C Keech


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