An Introduction to Statistics in Early Phase Trials

1. Auflage 2010
ISBN: 978-0-470-05985-2
Verlag: Wiley

Buch, Englisch, 272 Seiten, Format (B × H): 172 mm x 251 mm, Gewicht: 616 g

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.

Autoren/Hrsg.

Julious, Steven

Tan, Say Beng

Machin, David

Fachgebiete

• Mathematik | Informatik Mathematik Stochastik Wahrscheinlichkeitsrechnung
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Mathematik | Informatik Mathematik Stochastik Mathematische Statistik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik

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

Über Autor(innen)

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.