An Introduction To Statistics In Early Phase Trials

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.

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

"An Introduction to Statistics in Early Phase Trials" is an admirably concise and practical guide to the pertinent context, principles and formulae for statisticans inexpert in the application of their discipline to Phase I and II clinical research." (Clinical Research Best Practices, 1 November 2010)
“An Introduction to Statistics in Early Phase Trials provides concise descriptions of many early phase trial designs, along with the statistical equations necessary to gather and analyze the data” (Annals of Pharmacotherapy, 2010)

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