Medical Imaging in Clinical Trials

Editors: Miller, Colin, Krasnow, Joel, Schwartz, Lawrence H. (Eds.)

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About this book

In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Changes in the regulatory process has resulted, when it comes to the submission of data to the FDA, in a therapeutic agent where one or more of the trial end-points is the assessment of a radiological end-point. No longer is it sufficient to have the images read by the local investigator site.

The FDA has also identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials.

As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. An understanding of the methodology and the metrics is therefore required but difficult to ascertain in one easy to read volume for individuals entering this field. This book will therefore fulfill this void, be it for the pharmaceutical personnel from medical director to monitor, or the Principal Investigator who is having to understand the complexities of the imaging and why it is having to be sent off-site for a 'central read.'

Reviews

“Chapters are well organized throughout the book and provide detailed information. The chosen didactic style creates an easy-to-follow flow of information throughout the chapters. The book fulfills its goal of providing the key concepts of medical imaging applied in clinical trials. … Multidisciplinary clinical trial teams will enjoy the readily comprehensible information, carefully selected didactic elements, and excellent quality of illustrations.” (Peter Reimer, Radiology, Vol. 275 (2), May, 2015)


Table of contents (16 chapters)

  • Medical Imaging Modalities

    Ahmad, Harris A. (et al.)

    Pages 3-26

  • The Metrics and New Imaging Marker Qualification in Medical Imaging Modalities

    Miller, Colin G.

    Pages 27-45

  • Radiation Risks and Dosimetry Assessment

    Pearson, Derek

    Pages 47-63

  • Imaging Review Charters and Operational Considerations

    Perrone, Andrea M. (et al.)

    Pages 65-82

  • Defining the Radiological Blinded Read and Adjudication

    Miller, Colin G.

    Pages 83-97

Buy this book

eBook $139.00
price for USA (gross)
  • ISBN 978-1-84882-710-3
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Softcover $179.00
price for USA
  • ISBN 978-1-84882-709-7
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the ebook  
  • Rental duration: 1 or 6 month
  • low-cost access
  • online reader with highlighting and note-making option
  • can be used across all devices
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Bibliographic Information

Bibliographic Information
Book Title
Medical Imaging in Clinical Trials
Editors
  • Colin Miller
  • Joel Krasnow
  • Lawrence H. Schwartz
Copyright
2014
Publisher
Springer-Verlag London
Copyright Holder
Springer-Verlag London
eBook ISBN
978-1-84882-710-3
DOI
10.1007/978-1-84882-710-3
Softcover ISBN
978-1-84882-709-7
Edition Number
1
Number of Pages
XVIII, 420
Number of Illustrations and Tables
54 b/w illustrations, 57 illustrations in colour
Topics