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Index
Cover
Understanding Clinical Research
Copyright Page
Contents
Contributors
Foreword
Preface
SECTION I: EVOLUTION OF CLINICAL RESEARCH
CHAPTER ONE A Brief History of Clinical Trials, Drug Regulations, and the Food and Drug Administration
CHAPTER TWO Information Technology, Access, ClinicalTrials.gov
CHAPTER THREE The Role of Academic Research Organizations in Clinical Research
CHAPTER FOUR Ethics of Clinical Research: An Overview and Emerging Issues
SECTION II: PRINCIPLES OF CLINICAL EXPERIMENTATION
CHAPTER FIVE Introduction to Clinical Experimentation
CHAPTER SIX Phase I Trials: First in Human
CHAPTER SEVEN Phase II Clinical Trials
CHAPTER EIGHT Phase III and IV Clinical Trials
CHAPTER NINE Challenges of Clinical Trials in Pediatrics
SECTION III: OBSERVATIONAL RESEARCH
CHAPTER TEN Observational Research
CHAPTER ELEVEN Data Resources
CHAPTER TWELVE Observational Study Designs
CHAPTER THIRTEEN Challenges of Observational Designs
CHAPTER FOURTEEN Specific Regression Techniques
CHAPTER FIFTEEN Analytical Methods of Addressing Confounding
CHAPTER SIXTEEN Lessons from Notable Examples inObservational Research
Index
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