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Statistical Interactions in a Clinical Trial

  • Biostatistics: Original Research
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Abstract

New statisticians entering industry tend to “test statistical interactions” whenever there is a need. However, in many real-world applications, especially in clinical development of new drugs, most interactions need to be estimated, instead of tested. In this manuscript, the distinction between hypothesis testing and estimation will be articulated, and the use of statistical interactions in clinical development programs will be discussed. According to ICH E-9, the treatment by subgroup interaction should not be included in the prespecified primary statistical analysis model. The reasons behind this ICH E-9 recommendation are also clarified in this manuscript.

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Authors and Affiliations

  1. Boehringer-Ingelheim Pharmaceuticals, Inc, 900 Ridgebury Road, PO Box 368, Ridgefield, CT, 06877-0368, USA

    Naitee Ting PhD

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  1. Naitee Ting PhD
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Correspondence to Naitee Ting PhD.

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Ting, N. Statistical Interactions in a Clinical Trial. Ther Innov Regul Sci 52, 14–21 (2018). https://doi.org/10.1177/2168479017716491

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  • DOI: https://doi.org/10.1177/2168479017716491

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