Principles and Practice of Multi-site Randomized Controlled Trials in the Phase III Setting (electronic)

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This book is in electronic format, which does not allow printing or copying. You can read the book using Adobe Digital Editions. More information can be found here.

 

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.

Author: Peter Natale Peduzzi Ph.D.
Number of pages: 325
Language: English
Publisher: CARDET Press
Publication Year: 2018
Edition Number: 1st
ISBN: 978-9925-7363-1-7

 

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Description

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.

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