Discussion on the issue of sample size determination for a targeted to an untargeted and to a mixed effect model-based clinical trial design

Feng-shou Ko

Journal of Applied Statistics, 2018, vol. 45, issue 11, 2007-2019

Abstract: More and more studies have shown that genetic determinants may mediate variability among persons in the response to a drug. In other words, some therapeutics benefit only a subset of treated patients. Genomic technologies – such as DNA sequencing, mRNA transcript profiling, and comparative genomic hybridization – are providing biomarkers that can be used to predict which patients are most likely to respond to a given drug. In this paper, the sample size determination of a targeted clinical trial, an untargeted clinical trial and a random effect model is conducted. Treatment effect for the responder and non-responder patients, the assay specificity and sensitivity, and the proportion of the population for non-responder can affect sample size determination of the experimental design.

Date: 2018
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DOI: 10.1080/02664763.2017.1405915

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