The design and management of medical device clinical trials :
General Material Designation
[Book]
Other Title Information
strategies and challenges /
First Statement of Responsibility
Salah Abdel-aleem
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Hoboken, N.J. :
Name of Publisher, Distributor, etc.
John Wiley,
Date of Publication, Distribution, etc.
c2010
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xvii, 250 p. ;
Dimensions
25 cm
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index
CONTENTS NOTE
Text of Note
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