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

Product Description

In light of the Covid-19 Pandemic and in a bid to support researchers, students and learners during this strenuous period, CARDET Press and Dr Peter N. Peduzzi, Professor at Yale School of Public Health, have made the book available for Free. You can acquire it by following the normal procedure for purchases and proceeding to check out with no cost entailed.

This book is in electronic format, which does not allow printing or copying. You can read the book using ePub readers.

Free download for e-book readers (ePub) – See instructions 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.