11.1 Introduction

11.1.1 Background

Traditional clinical development of an experimental therapy utilizes the “one-size-fits-all” approach by testing the regimen in an unselected or untargeted patient population with a specific disease. The assumption is that response in the population with the disease is homogeneous. With the advent of molecularly targeted therapies, genetic engineering such as DNA sequencing and mRNA transcript profiling now makes a finer taxonomy of disease possible, which enables the development of precise diagnostic, prognostic, and therapeutic paradigms for specific subsets of patients, i.e. personalized medicine. Therefore, these targeted therapies may benefit only a subset of the entire population and may not benefit or ...

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