The design and management of medical device clinical trials :
[Book]
strategies and challenges /
Salah Abdel-aleem
Hoboken, N.J. :
John Wiley,
c2010
xvii, 250 p. ;
25 cm
Includes bibliographical references and index
Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research