Lopes Renato D. - Understanding Clinical Research

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Renato D. Lopes, editor

CHAPTER ONE
A Brief History of Clinical Trials, Drug Regulations, and the Food and Drug Administration

Nidhi Tripathi, Kate Davis, Catherine Bodine, and Daniel K. Benjamin Jr.

CHAPTER TWO
Information Technology, Access, ClinicalTrials.gov

Anjan K. Chakrabarti and C. Michael Gibson

CHAPTER THREE
The Role of Academic Research Organizations in Clinical Research

Craig J. Reist, Tyrus L. Rorick, Lisa G. Berdan, and Renato D. Lopes

CHAPTER FOUR
Ethics of Clinical Research: An Overview and Emerging Issues

Yee Weng Wong and Kevin A. Schulman

Daniel K. Benjamin Jr. and Karen S. Pieper, editors

CHAPTER FIVE
Introduction to Clinical Experimentation

Robert Bigelow

CHAPTER SIX
Phase I Trials: First in Human

Kevin M. Watt, Karen Chiswell, and Michael Cohen-Wolkowiez

CHAPTER SEVEN
Phase II Clinical Trials

Jeffrey T. Guptill and Karen Chiswell

CHAPTER EIGHT
Phase III and IV Clinical Trials

Gail E. Hafley, Sergio Leonardi, and Karen S. Pieper

CHAPTER NINE
Challenges of Clinical Trials in Pediatrics

Kevin N. Turner and P. Brian Smith

Lesley H. Curtis and Laine E. Thomas, editors

CHAPTER TEN
Observational Research

Michaela A. Dinan

CHAPTER ELEVEN
Data Resources

Ying Xian

CHAPTER TWELVE
Observational Study Designs

Bradley G. Hammill

CHAPTER THIRTEEN
Challenges of Observational Designs

David M. Vock

CHAPTER FOURTEEN
Specific Regression Techniques

Phillip J. Schulte and Laine E. Thomas

CHAPTER FIFTEEN
Analytical Methods of Addressing Confounding

Eric M. Reyes and Laine E. Thomas

CHAPTER SIXTEEN
Lessons from Notable Examples in Observational Research

Zubin J. Eapen

Daniel K. Benjamin Jr., MD, PhD

Professor of Pediatrics

Duke University School of Medicine

Faculty Associate Director

Duke Clinical Research Institute

Durham, North Carolina

Lisa G. Berdan, MHS, PA-C

Associate Director, Cardiovascular Megatrials

Duke Clinical Research Institute

Durham, North Carolina

Robert Bigelow, PhD

Associate Director

Duke Clinical Research Institute

Durham, North Carolina