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Sample size estimation for non‐inferiority trials of time‐to‐event data
Author(s) -
Crisp Adam,
Curtis Paula
Publication year - 2007
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.292
Subject(s) - sample size determination , statistics , event data , estimation , event (particle physics) , sample (material) , computer science , econometrics , mathematics , covariate , physics , chemistry , chromatography , quantum mechanics , economics , management
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.