Innovative Designs for Biomarker-Guided Trials

Jing Wang () and Mark Chang
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Jing Wang: Pfizer Inc.
Mark Chang: Veristat LLC

A chapter in Statistical Methods in Biomarker and Early Clinical Development, 2019, pp 53-65 from Springer

Abstract: Abstract Biomarkers are indispensable in the understanding of disease biology. It is believed that a validated biomarker with good predictive utility can offer a unique opportunity to guide clinical trial designs. Traditional clinical development of a novel therapy utilizes the “one-size-fits-all” approach by testing treatment effect in the entire patient population with a specific disease. It assumes that response in the disease population is homogeneous. However, many new therapeutic agents are molecularly targeted and might only benefit a subgroup of patients (Huang et al. 2015). If potential response heterogeneity between different patient subgroups was suspected through early stage biomarker research, it should be taken into account in the course of clinical development.

Date: 2019
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DOI: 10.1007/978-3-030-31503-0_4

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