Introduction to Randomized Controlled Clinical Trials, Second Edition [Paperback]

Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials provides a concise presentation of the principles applied in this area. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies.

This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented.

Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.WHAT IS A RANDOMIZED CONTROLLED TRIAL?
Definition and Key Features
Historical Context and the Nature of RCTS
Structure and Justification of RCTs
Exercises

BIAS
What is meant by bias in RCTs?
Types of Bias
Exercises

HOW MANY PATIENTS DO I NEED?
Criteria for Sample Size Calculations
Hypothesis Tests
Sample Size for a Normally Distributed Variable
Sample Size for a Binary Variable
General Remarks About Sample Size Calculations
Exercises

METHODS OF ALLOCATION
Simple Randomization
Random Permuted Blocks
Biased Coin Designs and Urn Schemes
Unequlƒ)