Simon Kirby

Christy Chuang-Stein

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria to the cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. 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. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm. 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. 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.

Quantitative Decisions in Drug Development

Morten H. Christiansen

What is it that makes us human? This is one of the most challenging and important questions we face. Our species' defining characteristic is language - we appear to be unique in the natural world in having such an incredibly open-ended system for putting thoughts into words. If we are to truly understand ourselves as a species we must understand the origins of this strange and unique ability. To do so, we need to answer some of the most intriguing questions in contemporary scientific research: Where did language come from? How did it evolve? Why are we unique in possessing it? This book, for the first time, brings together the leading thinkers who are trying to unlock the puzzle of language evolution. Here we see the latest ideas and theories from fields as diverse as anthropology, archaeology, artificial life, biology, cognitive science, linguistics, neuroscience, and psychology. In a series of seventeen well-written and accessible chapters we get an unrivalled view of the state of the art in this exciting area. Current controversies are revealed and new perspectives uncovered, in a clear and readable guide to the latest theories. This collection marks a major step forward in our quest to understand the origins and evolution of human language. In doing so it sheds new light on the process of evolution, the workings of the brain, the structure of language, and - most importantly - what it means to be human. Language Evolution is essential reading for researchers and students working in the areas covered, and has been used as a textbook for courses in the field. It will also attract the general reader who wants to know more about this fascinating subject.

Simon Kirby

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