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Exact sample size determination for the ratio of two incidence rates under the Poisson distribution

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Abstract

We present sample size determination using exact approaches for testing the ratio of incidence rates from a two-arm non-inferiority trial. The first approach is the exact conditional approach by treating the total number of events from two groups fixed, and the other is the exact unconditional approach based on maximization. Exact approaches guarantee the type I error rate which is often not satisfied in the commonly used asymptotic approaches on the basis of the corresponding limiting distributions of test statistics. We provide tables for sample size determination in commonly used cases in practice, and an example is used to show the application of these exact approaches. Sample size comparison using different exact approaches concludes that the exact unconditional approach based on the Wald-type test statistic has good performance in balanced studies.

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Acknowledgments

We would like to thank the Editor, the Associate Editor and two referees for their valuable comments and suggestions that helped to improve this manuscript.

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Authors and Affiliations

  1. Epidemiology and Biostatistics Program, Department of Environmental and Occupational Health, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV, 89154, USA

    Guogen Shan

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  1. Guogen Shan
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Correspondence to Guogen Shan.

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Shan, G. Exact sample size determination for the ratio of two incidence rates under the Poisson distribution. Comput Stat 31, 1633–1644 (2016). https://doi.org/10.1007/s00180-016-0654-6

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  • DOI: https://doi.org/10.1007/s00180-016-0654-6

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