Overview of the Book

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decision criteria, determining go/no-go decisions for progressing a drug candidate to the next stage, and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm.

Intended Audience

The book offers useful insights to statisticians, clinicians, regulatory affairs managers, and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization.

Additional Resources

The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.