Stephen S. Senn – författare

Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of:A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug developmentAn exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professionalAn examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effectsPerfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

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.

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.

Statistical Issues in Drug Development

The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.

This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of:

A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug developmentAn exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professionalAn examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects

Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

Statistical Issues in Drug Development

The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.

This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of:

A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug developmentAn exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professionalAn examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects

Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

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.

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.