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Informationen zum Autor 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. Klappentext 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 trialsAn 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. Zusammenfassung 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. Inhaltsverzeichnis 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 ...
