Full Description
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.
Contents
Chapter 1 Early phase trials 1
Chapter 2 Introduction to pharmacokinetics 13
Chapter 3 Sample size calculations for clinical trials 37
Chapter 4 Crossover trial basics 55
Chapter 5 Multi-period crossover trials 71
Chapter 6 First time into man 87
Chapter 7 Bayesian and frequentist methods 113
Chapter 8 First-time-into-new-population studies 125
Chapter 9 Bioequivalence studies 139
Chapter 10 Other Phase I trials 169
Chapter 11 Phase II trials: general issues 187
Chapter 12 Dose-response studies 197
Chapter 13 Phase II trials with toxic therapies 211
Chapter 14 Interpreting and applying early phase trial results 223
Chapter 15 Go/No-Go criteria 231
Appendix 245
References 251
Index 257
