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. Read more...
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
Content: Front cover
Contents
List of figures
List of tables
Preface
Author Attribution
CHAPTER 1. Introduction to Clinical Trials
CHAPTER 2. Defining the Question
CHAPTER 3. Study Design
CHAPTER 4. Sample Size
CHAPTER 5. Randomization
CHAPTER 6. Data Collection and Quality Control
CHAPTER 7. Survival Analysis
CHAPTER 8. Longitudinal Data
CHAPTER 9. Quality of Life
CHAPTER 10. Data Monitoring and Interim Analysis
CHAPTER 11. Selected Issues in the Analysis
CHAPTER 12. Closeout and Reporting
APPENDIX A. Delta Method, Maximum Likelihood Theory, and Information
References
Back cover
