Stephen S. Senn

Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. * Comprehensive coverage of the design and analysis of cross-over trials. * Each technique is carefully explained and the mathematics is kept to a minimum. * Features many real and original examples, taken from the author's vast experience. * Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. * Written in a style suitable for statisticians and physicians alike. * Computer programs to accompany the examples in the book can be downloaded from the Web Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.

Cross-over Trials in Clinical Research

Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This highly readable second edition has been updated to include: Comprehensive coverage of the design and interpretation of clinical trials. Expanded sections on missing data, equivalence, meta-analysis and dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

Statistical Issues in Drug Development

Philip Dawid

Mike Christie

Andrew Cliffe

Several points of disagreement exist between different modelling traditions as to whether complex models are always better than simpler models, as to how to combine results from different models and how to propagate model uncertainty into forecasts. This book represents the result of collaboration between scientists from many disciplines to show how these conflicts can be resolved. Key Features: Introduces important concepts in modelling, outlining different traditions in the use of simple and complex modelling in statistics. Provides numerous case studies on complex modelling, such as climate change, flood risk and new drug development. Concentrates on varying models, including flood risk analysis models, the petrol industry forecasts and summarizes the evolution of water distribution systems. Written by experienced statisticians and engineers in order to facilitate communication between modellers in different disciplines. Provides a glossary giving terms commonly used in different modelling traditions. This book provides a much-needed reference guide to approaching statistical modelling. Scientists involved with modelling complex systems in areas such as climate change, flood prediction and prevention, financial market modelling and systems engineering will benefit from this book. It will also be a useful source of modelling case histories.

Simplicity, Complexity and Modelling

Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. * Comprehensive coverage of the design and analysis of cross-over trials. * Each technique is carefully explained and the mathematics is kept to a minimum. * Features many real and original examples, taken from the author's vast experience. * Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. * Written in a style suitable for statisticians and physicians alike. Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.

Stephen S. Senn

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