An Introduction to Statistics in Early Phase Trials

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An Introduction to Statistics in Early Phase Trials

Steven Julious,Say Beng Tan,David Machin

Available on Wiley Online Library

Description

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.

About the Author

Steven A. Julious, Senior Lecturer in Medical Statistics
Medical Statistics Unit, Institute of General Practice and Community Care, University of Sheffield, Community Sciences Centre, Northern General Hospital, Herries Road, Sheffield, UK

Say-Beng Tan, Senior Biostatistician, Singapore Clinical Research Institute Duke-NUS Graduate Medical School, Singapore

David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and United Kingdom Children’s Cancer Study Group, University of Leicester, UK and Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

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