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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A Frequentist Decision-Making Framework,. Procedures for assessing evidence and making decisions under the Frequentist approach are calibrated by how they would perform were they used repeatedly. We discuss challenges associated with the interpretation of .-values in the presence of multiplicity and selective inference.

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Characteristics of a Diagnostic Test,view the metrics commonly used to characterize the performance of a diagnostic test. We then discuss what it means when a diagnostic test returns a positive or a negative result. We illustrate the discussion with the use of several decision rules.

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Clinical Testing of a New Drug,d for emergency use through extensive public–private partnerships and the adoption of a high-risk business model. We offer some examples of recent advances in clinical trial designs and conclude the chapter with a short summary of the salient points covered in the chapter.

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The Parallel Between Clinical Trials and Diagnostic Tests,reproducibility is briefly discussed. We end the chapter by highlighting the difference between statistical power and the probability of a positive trial. This last point becomes more important as a new drug moves through the various development stages as will be illustrated in Chap. ..

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Designing Proof-of-Concept Trials with Desired Characteristics, can be considered as special cases of the LPDAT approach. We review the metrics introduced in Chap. . in the context of these five design types. We show how prior information on historical controls can be used to help plan a POC study and share an example on this application involving a rare disease.

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Designing Confirmatory Trials with Desired Characteristics,e hypothesis-testing perspective. In addition, we discuss factors that could affect POSS and how these factors should be incorporated into the planning of the confirmatory program. The chapter highlights the importance of a robust investment in Phase 2 development in order to achieve a desirable level of POSS at the Phase 3 stage.

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