Health Policy and Issues

Understanding Clinical Research

Robert A. Harrington, Renato D. Lopes

ISBN: 9780071746786 / 0071746781

Table of Contents

Section One - Evolution of Clinical Research

Chapter 1. A Brief History of Clinical Trials, Drug Regulations, and the Food and Drug Administration
Chapter 2. Information Technology, Access,
Chapter 3. The Role of Academic Research Organizations in Clinical Research
Chapter 4. Ethics of Clinical Research: An Overview and Emerging Issues

Section Two - Principles of Clinical Experimentation

Chapter 5. Introduction to clinical experimentation
Chapter 6. Phase I Trials: First in Human
Chapter 7. Phase II Clinical Trials
Chapter 8. Phase III and IV Clinical Trials
Chapter 9. Challenges of Clinical Trials in Pediatrics

Section Three - Observational Research

Chapter 10. Observational Research
Chapter 11. Data Resources
Chapter 12. Observational Study Designs
Chapter 13. Challenges of Observational Designs
Chapter 14. Specific Regression Techniques
Chapter 15. Analytical Methods of Addressing Confounding
Chapter 16. Lessons from Notable Examples in Observational Research