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Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program

Title
Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program

Abstract
The decision to incorporate the specific evaluation of a candidate companion diagnostic (CDx) in a clinical development plan (CDP) is often difficult and is exacerbated by the lack of relevant decision tools. In this article, we discuss a novel methodology to assess the probability of technical success (PTS) of a CDP that adequately evaluates a CDx compared with a CDP that does not. We propose splitting the PTS into subjective (biological uncertainty) and quantitative (clinical uncertainty) components, assessing each separately and then combining them in a decision theoretic manner to obtain an overall success probability of a CDP with and without a CDx.