Abstract
When faced with the myriad challenges in drug development, the discipline of Statistics (recognized by the use of an upper case “S”) is “the knight in shining armor” that rides to our assistance and facilitates the collection, analysis, and interpretation of optimal-quality data as the basis for rational decision-making at all stages of the process (Durham and Turner 2008). In this and the following two chapters, we have resisted the temptation to provide exhaustive discussion of subtle nuances of statistical analysis: our interest in the discipline of Statistics is a pragmatic one since it provides the best way currently available to conduct clinical development programs.
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