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- W2004699731 abstract "We consider the problem of sample size calculation for non-inferiority based on the hazard ratio in time-to-event trials where overall study duration is fixed and subject enrolment is staggered with variable follow-up. An adaptation of previously developed formulae for the superiority framework is presented that specifically allows for effect reversal under the non-inferiority setting, and its consequent effect on variance. Empirical performance is assessed through a small simulation study, and an example based on an ongoing trial is presented. The formulae are straightforward to program and may prove a useful tool in planning trials of this type. Copyright © 2007 John Wiley & Sons, Ltd." @default.
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- W2004699731 date "2008-10-01" @default.
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- W2004699731 title "Sample size estimation for non-inferiority trials of time-to-event data" @default.
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- W2004699731 doi "https://doi.org/10.1002/pst.292" @default.
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