An Introduction to Statistics in Early Phase Trials

An Introduction to Statistics in Early Phase Trials

By: David Machin (author), Steven A. Julious (author), Say-Beng Tan (author)Hardback

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Description

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.

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About Author

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

Contents

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

Product Details

  • publication date: 16/03/2010
  • ISBN13: 9780470059852
  • Format: Hardback
  • Number Of Pages: 264
  • ID: 9780470059852
  • weight: 628
  • ISBN10: 0470059850

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