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:

10.1201/9781351110273-140000293

 Download Chapter

 

Abstract

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.

 Cite
Search for more...
Back to top

Use of cookies on this website

We are using cookies to provide statistics that help us give you the best experience of our site. You can find out more in our Privacy Policy. By continuing to use the site you are agreeing to our use of cookies.