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.
Зміст
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
Про автора
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.
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