Journal
STATISTICS IN MEDICINE
Volume 20, Issue 4, Pages 557-579Publisher
WILEY
DOI: 10.1002/sim.693
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Funding
- NCI NIH HHS [CA 39929] Funding Source: Medline
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In this paper we propose formulae for calculating the expected number of events or, alternatively, the required trial duration, for clinical trials involving two treatment groups in which patients may potentially experience multiple events and the data will be analysed using a multiplicative intensity (MI) model. We use a partial likelihood-based approach and examine in detail two MI models: one that includes a binary treatment variable as the only covariate and a three-state Markov process model in which a binary time-varying covariate is added to the previous model. For the simpler model, our formula coincides with those derived by Cook using full likelihood methods. We present applications of the derived formulae to chronic granulomatous disease and breast cancer data sets. Copyright (C) 2001 John Wiley & Sons, Ltd.
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