Main description:

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.

Contents:

What is a Randomized Controlled Trial? Bias. How Many Patients Do I Need? Methods of Allocation. Assessment, Blinding and Placebos. Analysis of Results. Further Analysis: Binary and Survival Data. Monitoring Accumulating Data. Subgroups and Multiple Outcomes. Protocols and Protocol Deviations. Some Special Designs: Crossovers, Equivalence and Clusters. Meta-Analyses of Clinical Trials. Further Reading. Solutions to Exercises. References.