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.'
