Clinical Trials: A Practical Approach.

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.