Details

An Introduction to Statistics in Early Phase Trials


An Introduction to Statistics in Early Phase Trials


1. Aufl.

von: Steven Julious, Say-Beng Tan, David Machin

86,99 €

Verlag: Wiley
Format: PDF
Veröffentl.: 19.01.2010
ISBN/EAN: 9780470319178
Sprache: englisch
Anzahl Seiten: 264

DRM-geschütztes eBook, Sie benötigen z.B. Adobe Digital Editions und eine Adobe ID zum Lesen.

Beschreibungen

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.
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 trial results Chapter 15 Go/No-Go criteria Appendix References Index
"An Introduction to Statistics in Early Phase Trials" is an admirably concise and practical guide to the pertinent context, principles and formulae for statisticians inexpert in the application of their discipline to Phase I and II clinical research". (Journal of Clinical Research Best Practices, 1 March 2011) “An Introduction to Statistics in Early Phase Trials provides concise descriptions of many early phase trial designs, along with the statistical equations necessary to gather and analyze the data” (Annals of Pharmacotherapy, 2010) "I enjoyed reading the work of Dr. Julious, Tan, and Machin,found it quite useful, and recommend it to others teaching about, working with, or considering work in the learning phase of drug development." (Journal of Biopharmaceutical Statistics, 2011)
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
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.

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