Table of Contents

Introduction: The Rationale of Clinical Trials.

The Historical Development of Clinical Trials.

Organization and Planning.

The Justificaton for Randomized Controlled Trials.

Methods of Randomization.

Blinding and Placebos.

Ethical Issues.

Crossover Trials.

The Size of a Clinical Trial.

Monitoring Trial Progress.

Forms and Data Management.

Protocol Deviations.

Basic Principles of Statistical Analysis.

Further Aspects of Data Analysis.

Publication and Interpretation of Findings.

References.

Index.

About the Author

Stuart J. Pocock is a British medical statistician. He has been professor of medical statistics at the London School of Hygiene and Tropical Medicine since 1989. His research interests include statistical methods for the design, monitoring, analysis and reporting of randomized clinical trials.