Clinical Evaluation of Medical Devices

Part I.Fundamentals of Clinical Study Design and Evaluation

1. Clinical Trials in Development and Marketing of Medical Devices
Karen M. Becker

2. Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics
Daniel A. Kracov, Lisa M. Dwyer

3. Requirements for Medicare Coverage and Reimbursement for Medical Devices
Esther R. Scherb, Stuart S. Kurlander

4. Postmarket Requirements for Significant Risk Devices
Suzan Onel

5. Applications of Bayesian Methods to Medical Device Trials
Telba Z. Irony, Richard Simon

6. Intellectual Property Protection for Medical Devices
Fariborz Moazzam, Michael D. Bednarek

7. HIPAA Compliance in Clinical Research
Peter M. Kazon, Sharon D. Brooks

8. Overview of Medicare Coverage of Clinical Trials
Julie K. Taitsman

9. Developing Drug-Device Combination Products With Unapproved Components
Guy Chamberland

10. Wall Street’s Perspective on Medical Device Evaluation
Adam K. Galeon

II.Case Studies

11. Challenges in Conducting Implantable Device Trials
Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides, Deborah V. Davis Ascheim

12. BELIEF
Jan Erik Nordrehaug, Janet M. Fauls

13. Clinical Trials of an Anti-Adhesion Adjuvant
Michael P. Diamond

14. Use of Multiple Imputation Models in Medical Device Trials
Donald B. Rubin, Samantha R. Cook

15. Case Studies on the Local Coverage Process
Mitchell I. Burken

16. Reimbursement Analysis
Robin Bostic

17. Polyurethane Pacemaker Leads
Ken Stokes

18. Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves
Frederick J. Schoen

19. The Use of Surrogate Outcome Measures
John J. Whyte

DRM-restrictions

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Avainsanat: SCIENCE / Chemistry / General SCI013000