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

Publication subTitle ：Strategies and Challenges

Author： Salah M. Abdel-aleem  

Publisher： John Wiley & Sons Inc‎

Publication year： 2011

E-ISBN: 9781118164624

P-ISBN(Hardback):  9780470602256

Subject： R197.39 Medical equipment and facility

Language： ENG

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Description

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.

Chapter

Contents

pp.：  1 – 9

List of Abbreviations

pp.：  9 – 13

Preface

pp.：  13 – 15

Acknowledgments

pp.：  15 – 19

1. Challenges to the Design of Clinical Study

pp.：  19 – 20

2. Challenges to Managing the Study

pp.：  20 – 62

3. Selection of Historic Controls

pp.：  62 – 90

4. Fraud and Misconduct in Clinical Trials

pp.：  90 – 118

5. Challenges to the Regulation of Medical Device

pp.：  118 – 126

6. Challenges of Global Clinical Studies and the CE Mark Process

pp.：  126 – 156

7. Challenging FDA PMA Cases

pp.：  156 – 182

8. Bioethics in Clinical Research

pp.：  182 – 218

Glossary of Clinical, CE Mark, and Statistical Terms

pp.：  218 – 230

References

pp.：  230 – 236

Index

pp.：  236 – 240

LastPages

pp.：  240 – 269

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