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Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and in...
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.
As a result of the COVID-19 pandemic, medical statistics and public health data have become staples of newsfeeds worldwide, with infection rates, deaths, case fatality and the mysterious R figure featuring regularly. However, we don't all have the statistical background needed to translate this information into knowledge. In this lively account, Stephen Senn explains these statistical phenomena and demonstrates how statistics is essential to making rational decisions about medical care. The second edition has been thoroughly updated to cover developments of the last two decades and includes a new chapter on medical statistical challenges of COVID-19, along with additional material on infectious disease modelling and representation of women in clinical trials. Senn entertains with anecdotes, puzzles and paradoxes, while tackling big themes including: clinical trials and the development of medicines, life tables, vaccines and their risks or lack of them, smoking and lung cancer, and even the power of prayer.
If you think that statistics has nothing to say about what you do or how you could do it better, then you are either wrong or in need of a more interesting job. Stephen Senn explains here how statistics determines many decisions about medical care, from allocating resources for health, to determining which drugs to license, to cause-and-effect in relation to disease. He tackles big themes: clinical trials and the development of medicines, life tables, vaccines and their risks or lack of them, smoking and lung cancer and even the power of prayer. He entertains with puzzles and paradoxes and covers the lives of famous statistical pioneers. By the end of the book the reader will see how reasoning with probability is essential to making rational decisions in medicine, and how and when it can guide us when faced with choices that impact on our health and even life.
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 encouragin...
Unlock today's statistical controversies and irreproducible results by viewing statistics as probing and controlling errors.
John Nelder was one of the most influential statisticians of his generation, having made an impact on many parts of the discipline. This book contains reviews of some of those areas, written by top researchers. It is accessible to non-specialists, and is noteworthy for its breadth of coverage.
Liturgy with a Difference gathers a broad range of international theologians and scholars to interrogate current practices of liturgy and worship in order to unmask ways in which dehumanizing majoritarianisms and presumed norms of gender, culture, ethnicity, and body, among others, remain at work in congregations.
Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials. * The various approaches are presented within a general unified framework. * Meta-analysis techniques are described in detail, from their theoretical devel...
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