Principles and Practice of Multi-site Randomized Controlled Trials in the Phase III Setting (electronic)
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The focus of this book is to provide a foundation in the principles and practice of multi-site, Randomized Controlled Trials (RCT), primarily in the phase III setting. Although regulatory issues are discussed, the design and conduct of clinical trials for regulatory approval are not covered, nor are early phase clinical trials in the phase I or II setting. Any regulatory issues presented are primarily based on U.S. FDA and International Conference on Harmonization (ICH) guidelines. The text covers practical issues related to the design, conduct, monitoring and analysis of multi-site trials that are illustrated with case studies. Exercises at the end of each chapter are designed to supplement and to enhance the material presented in the text. Many of the exercises are based on issues that have arisen in clinical trials. Brief statistical notes are also given throughout the text to provide more technical details with appropriate references for more in depth coverage. The book will help readers to (1). develop an understanding of the principles and practice of randomized clinical trials; (2) apply these principles to the design of a RCT; (3) critically review a RCT; and (4) report the findings of a RCT.
This volume provides the framework for reading promotion, grounded on solid empirical research conducted in several EU countries. It presents research findings and it provides practical guidelines for desinging and implementing reading promotion actions.