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Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome

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  • Barry Kurt Moser
  • Susan Halabi

Abstract

In this paper, we develop the methodology for designing clinical trials with any factorial arrangement when the primary outcome is time to event. We provide a matrix formulation for calculating the sample size and study duration necessary to test any effect with a prespecified type I error rate and power. Assuming that a time to event follows an exponential distribution, we describe the relationships between the effect size, the power, and the sample size. We present examples for illustration purposes. We provide a simulation study to verify the numerical calculations of the expected number of events and the duration of the trial. The change in the power produced by a reduced number of observations or by accruing no patients to certain factorial combinations is also described.

Suggested Citation

  • Barry Kurt Moser & Susan Halabi, 2015. "Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome," Communications in Statistics - Theory and Methods, Taylor & Francis Journals, vol. 44(2), pages 275-285, January.
    • Handle: RePEc:taf:lstaxx:v:44:y:2015:i:2:p:275-285
    DOI: 10.1080/03610926.2012.705940
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