An Introduction to Statistics in Early Phase Trials

Steven A. Julious, Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK
 
Say-Beng Tan, Singapore Clinical Research Institute and Duke-NUS Graduate Medical School, Singapore
 
David Machin, Children's Cancer and Leukaemia Group (CCLG), University of Leicester, UK

All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained.
 
* Conveys key ideas in a concise manner understandable by non-statisticians
* Explains how to optimise designs in a constrained or fixed resource setting
* Discusses decision making criteria at the end of Phase II trials
* Highlights practical day-to-day issues and reporting of early phase trials
 

An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.

This guide offers an overview of the most common types of trial undertaken in early clinical development. The coverage discusses the different methodologies and the impact of new technologies, both clinical and statistical, on clinical development.

Chapter 1 Early phase trials
 
Chapter 2 Introduction to pharmacokinetics
 
Chapter 3 Sample size calculations for clinical trials
 
Chapter 4 Crossover trial basics
 
Chapter 5 Multi-period crossover trials
 
Chapter 6 First time into man
 
Chapter 7 Bayesian and frequentist methods
 
Chapter 8 First-time-into-new-population studies
 
Chapter 9 Bioequivalence studies
 
Chapter 10 Other Phase I trials
 
Chapter 11 Phase II trials: general issues
 
Chapter 12 Dose-response studies
 
Chapter 13 Phase II trials with toxic therapies
 
Chapter 14 Interpreting and applying early phase trial results
 
Chapter 15 Go/No-Go criteria
 
Appendix
 
References
 
Index

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