The Simon’s two-stage design accounting for genetic heterogeneity

Feng-shou Ko

Communications in Statistics - Theory and Methods, 2024, vol. 53, issue 7, 2661-2669

Abstract: Over the past decades, the process of the traditional drug discovery study spent tremendous time and resources. More and more studies have shown that genetic determinants may mediate variability among persons in the response to a drug. In this article, the proposed method is considered for genetic heterogeneity in Simon’s two-stage design for a phase II clinical trial. We try to propose the method to employ the phase II clinical trial based on the existence of the epidemiological evidence for genetic heterogeneity. For our proposed method, Simon’s two-stage design is conditional on the probability of the genetic heterogeneity. The example is used to illustrate how to calculate sample size in given parameters.

Date: 2024
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DOI: 10.1080/03610926.2022.2148469

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