The Design and Management of Medical Device clinical Trials: Strategies and Challenges

Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.Content:
Chapter 1 Challenges to the Design of Clinical Study (pages 1–42):
Chapter 2 Challenges to Managing the Study (pages 43–70):
Chapter 3 Selection of Historic Controls (pages 71–97):
Chapter 4 Fraud and Misconduct in Clinical Trials (pages 99–105):
Chapter 5 Challenges to the Regulation of Medical Device (pages 107–135):
Chapter 6 Challenges of Global Clinical Studies and the CE Mark Process (pages 137–161):
Chapter 7 Challenging FDA PMA Cases (pages 163–197):
Chapter 8 Bioethics in Clinical Research (pages 199–210):