Additional statistical considerations in clinical trials

The previous chapters have provided you with an introduction to statistical methods and analyses that are commonly used in pharmaceutical clinical trials, with an emphasis on therapeutic confirmatory trials. Although we certainly have not covered all of the analyses that can be conducted in these trials, those that we have discussed have given you a solid foundation that will also enable you to understand the basics of other analyses. 

In this chapter we highlight additional statistical considerations relevant to therapeutic confirmatory trials, and other study designs that also provide important information upon which to base decision-making. These additional insights and information build upon the material presented so far. As this chapter is largely conceptual rather than computational, we have included a number of references to guide your further reading. 

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Chapter 1 2 Additional statistical considerations in clinical trials... 

It is appropriate here to highlight the additional ethical responsibilities that are shouldered by those involved in statistical aspects of clinical trials, as outlined in the operational definition of Statistics presented in Chapter 1. Derenzo and Moss (2006) addressed the importance of ethical considerations in scientific and statistical aspects of clinical studies ... 

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