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Medical Imaging in Clinical Trials (Paperback, 2014 ed.)
Loot Price: R5,357
Discovery Miles 53 570
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Medical Imaging in Clinical Trials (Paperback, 2014 ed.)
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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.'
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