Titlebook: Quantitative Decisions in Drug Development; Christy Chuang-Stein,Simon Kirby Book 2021Latest edition The Editor(s) (if applicable) and The

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Other Metrics That Have Been Proposed to Optimize Drug Development Decisions,into their decision process. In this chapter, we review two approaches that have been proposed to quantitatively incorporate cost into design considerations. The first one optimizes a benefit–cost efficiency score that measures the cost-effectiveness of a proof-of-concept trial design. The second ap

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Additional Topics,ssessment of program-level success probability when a program includes multiple studies in different phases of a disease, joint analysis of efficacy and safety endpoints, using prior information at the pre-clinical stage, and sources for data and information. We caution about changes in statistical

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