The role of clinical trials in new drug development

This chapter provides an overview of the process of new drug development. It introduces you to this process in a relatively succinct way, but still provides enough details for you to understand the relevance and importance of the statistical methodologies discussed in the following chapters. 

This list of attributes provides a good map for our discussions in this chapter. 

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Chapter 2 The role of clinical trials in new drug development... 

This book, therefore, is a self-contained introduction to the discipline of Statistics and its use in therapeutic confirmatory clinical trials. The first part of the book provides introductory comments about the discipline of Statistics and lays the foundations for our later discussions in the context of pharmaceutical trials. Chapter 2 presents an overview of the process of new drug development and the role of clinical trials in this process. The categories of different types of clinical trials are identified and discussed so that you will understand thetypes of data collectedin them. 

Nearly 40% of drug candidates fail in clinical trials because of poor ADME. Today, it is widely accepted that ADME prediction plays a critical role in new drug development and that focusing on promising compounds will dramatically reduce the amount of wasted time and resources in the overall development process. Generally, two approaches exist for ADME prediction. 

This book, which focuses on biological considerations in clinical trials, is written very much in this spirit. While study design, experimental methodology, and statistical analysis are central characters in our discussions of new drug development, their importance lies in their role in the development of drugs that influence a patient s biology for the better. 

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