Design, Methodology, and Analysis

New Drug Development Design, Methodology, and Analysis. By J. Rick Turner Copyright 2007 John Wiley Sons, Inc. 

The structural architecture for this book is presented schematically in Figure 1.1. This model comprises three components design, methodology, and analysis. These components operate together in a process that is integrative, interactive, and ideally seamless. These components are three of the four central characters in this book The fourth central character is identified in Section 1.11. 

Figure 1.1. Design, methodology, and analysis in drug development.

Early-phase clinical studies involve relatively small numbers of subjects. However, this does not mean that design, methodology, and analysis are any less critical. Machin and Campbell (2005) noted that these early-phase clinical studies... 

While the nature of the analyses of data from therapeutic confirmatory clinical trials is relatively straightforward compared with those undertaken in earlier stages of clinical development, supreme care should again be taken in all aspects of design, methodology, and analysis, since only then can optimum quality data be used to provide optimum answers to well-constructed research questions. Chapter 10 noted that safety data are typically presented descriptively at this time but that this may change in due course. By the time that therapeutic confirmatory trials are conducted, there should be a small number of precisely asked research questions that address the efficacy of the drug. 

Turner New Drug Development Design, Methodology, and Analysis... 

New drug development design, methodology, and analysis / J. Rick Turner, p. cm. 

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