Clinical Trial: N -of-1 Design Analysis

Authored by: Can Cui , Shein-Chung Chow

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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The development of biosimilar products provides a more affordable alternative to general patient population, compared to the brand-name products. However, the availability of more and more biosimilar products in the marketplace also raises a critical issue, that is, whether these biosimilars can be used interchangeably with the brand-name products is unknown. To this end, a crossover design is necessarily employed. In this entry, we focus on the advantages of complete N-of-1 designs compared to the commonly used crossover designs. Specifically, the relative efficiency and power analysis are performed for the complete N-of-1 designs with two, three, and four dosing periods. As a result, complete N-of-1 designs are more efficient and require less sample size in clinical trials. Therefore, complete N-of-1 designs are superior than partial designs in general and can potentially work for the evaluation in rare diseases.

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