Julious / Tan / Machin An Introduction to Statistics in Early Phase Trials

1. Auflage 2010
ISBN: 978-0-470-31917-8
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 264 Seiten, E-Book

All new medicines and devices undergo early phase trials to assess,interpret and better understand their efficacy, tolerability andsafety. An Introduction to Statistics in Early Phase Trialsdescribes the practical design and analysis of these importantearly phase clinical trials and provides the crucial statisticalbasis for their interpretation. It clearly and concisely providesan overview of the most common types of trials undertaken in earlyphase clinical research and explains the different methodologiesused. The impact of statistical technologies on clinicaldevelopment and the statistical and methodological basis for makingclinical and investment decisions are also explained.
* Conveys key ideas in a concise manner understandable bynon-statisticians
* Explains how to optimise designs in a constrained or fixedresource setting
* Discusses decision making criteria at the end of Phase IItrials
* Highlights practical day-to-day issues and reporting of earlyphase trials
An Introduction to Statistics in Early Phase Trials is anessential guide for all researchers working in early phase clinicaltrial development, from clinical pharmacologists andpharmacokineticists through to clinical investigators and medicalstatisticians. It is also a valuable reference for teachers andstudents of pharmaceutical medicine learning about the design andanalysis of clinical trials.

Autoren/Hrsg.

Julious, Steven

Tan, Say-Beng

Machin, David

Inhaltsverzeichnis

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 trialresults
Chapter 15 Go/No-Go criteria
Appendix
References
Index

Über Autor(innen)

Steven A. Julious, Medical Statistics Group, School ofHealth and Related Research, University of Sheffield, UK
Say-Beng Tan, Singapore Clinical Research Institute and Duke-NUSGraduate Medical School, Singapore
David Machin, Children's Cancer and Leukaemia Group (CCLG),University of Leicester, UK