Introduction to Statistical Methods for Clinical Trials

PREFACE Introduction to Clinical Trials History and Background Ethics of Clinical Research Types of Research Design and Types of Trials The Need for Clinical Trials The Randomization Principle Timing of a Clinical Trial Trial Organization Protocol and Manual of Operations Regulatory Issues Overview of the Book Defining the Question Statistical Framework Elements of Study Question Outcome or Response Measures The Surrogate Outcome Composite Outcomes Summary Problems Study Design Early Phase Trials Phase III/IV Trials Non-Inferiority Designs Scr.
Abstract: PREFACE Introduction to Clinical Trials History and Background Ethics of Clinical Research Types of Research Design and Types of Trials The Need for Clinical Trials The Randomization Principle Timing of a Clinical Trial Trial Organization Protocol and Manual of Operations Regulatory Issues Overview of the Book Defining the Question Statistical Framework Elements of Study Question Outcome or Response Measures The Surrogate Outcome Composite Outcomes Summary Problems Study Design Early Phase Trials Phase III/IV Trials Non-Inferiority Designs Scr