The design and management of medical device clinical trials
Subtitle: strategies and challenges
By: Salah Abdel-aleem.
Publisher: John Wiley
Published: 2010
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470602256
Subjects: Medical instruments and apparatus -- Research; Clinical trials; Clinical Trials as Topic -- methods; Equipment and Supplies; Device Approval
Notes: Includes bibliographical references and index.
Table of contents: title: Challenges to the design of clinical study; title: Challenges to managing the study; title: Selection of historic controls; title: Fraud and misconduct in clinical trials; title: Challenges to the regulation of medical device; title: Challenges of global clinical studies and the CE mark process; title: Challenging FDA PMA cases; title: Bioethics in clinincal research.