Clinical Trials: A Practical Approach

Clinical Trials A Practical Approach Stuart J. Pocock Professor of Medical Statistics and Director of Clinical Trials Research Group London School of Hygiene and Tropical Medicine, University of London, UK It is well recognized that randomized clinical trials play an important role in the evaluation of new treatments. However, the reliable achievement of genuine patient benefit depends on clinical trials being well organized and conducted according to proper ethical and scientific standards. This comprehensive text on the principles and practice of clinical trials gives a detailed account of how to conduct trials and also provides a general perspective on their historical development, current status and future strategy. Each aspect of clinical trial design, analysis and interpretation is described in a non–technical manner and illustrated by actual trials. In particular, relevant statistical methods are clearly explained for clinicians and others without statistical training. This book will be essential reading for clinicians, statisticians, medical students, the pharmaceutical industry and anyone wishing to acquire a true understanding of clinical trials. ′The purpose of this book is to explain in practical terms the basic principles of clinical trials. ... This book succeeds admirably in this aim and is accessible to a wide audience, including clinical investigators, statisticians, and those involved in data management and the administration of clinical trials.′ Controlled Clinical Trials ′This book is an outstanding practical guide to the design, planning, execution and analysis of clinical trials.′ Journal of the Royal Society of Medicine ′Pocock′s book is a helpful and thoughtful one ... of considerable value to clinicians who are drawn into clinical trials.′ The Lancet ′This is an excellent book ... which will be of value to anyone beginning work in the field of clinical trials, but at the same time it pro vides a useful reference work for those already experienced in clinical trials.′ Trends in Pharmacological Sciences

Spis treści:
Introduction: The Rationale of Clinical Trials.
The Historical Development of Clinical Trials.
Organization and Planning.
The Justificaton for Randomized Controlled Trials.
Methods of Randomization.
Blinding and Placebos.
Ethical Issues.
Crossover Trials.
The Size of a Clinical Trial.
Monitoring Trial Progress.
Forms and Data Management.
Protocol Deviations.
Basic Principles of Statistical Analysis.
Further Aspects of Data Analysis.
Publication and Interpretation of Findings.
References.
Index.

Okładka tylna:
Clinical Trials A Practical Approach Stuart J. Pocock Professor of Medical Statistics and Director of Clinical Trials Research Group London School of Hygiene and Tropical Medicine, University of London, UK It is well recognized that randomized clinical trials play an important role in the evaluation of new treatments. However, the reliable achievement of genuine patient benefit depends on clinical trials being well organized and conducted according to proper ethical and scientific standards. This comprehensive text on the principles and practice of clinical trials gives a detailed account of how to conduct trials and also provides a general perspective on their historical development, current status and future strategy. Each aspect of clinical trial design, analysis and interpretation is described in a non–technical manner and illustrated by actual trials. In particular, relevant statistical methods are clearly explained for clinicians and others without statistical training. This book will be essential reading for clinicians, statisticians, medical students, the pharmaceutical industry and anyone wishing to acquire a true understanding of clinical trials. ′The purpose of this book is to explain in practical terms the basic p rinciples of clinical trials. ... This book succeeds admirably in this aim and is accessible to a wide audience, including clinical investigators, statisticians, and those involved in data management and the administration of clinical trials.′ Controlled Clinical Trials ′This book is an outstanding practical guide to the design, planning, execution and analysis of clinical trials.′ Journal of the Royal Society of Medicine ′Pocock′s book is a helpful and thoughtful one ... of considerable value to clinicians who are drawn into clinical trials.′ The Lancet ′This is an excellent book ... which will be of value to anyone beginning work in the field of clinical trials, but at the same time it provides a useful reference work for those already experienced in clinical trials.′ Trends in Pharmacological Sciences