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.'
Medical Imaging in Clinical Trials is a key text in understanding the methodology and the metrics that are required in the field of medical imaging. As the pharmaceutical, biotech and medical device industries continue to identify ways to improve and speed up product development, medical imaging plays a more significant role.
Medical Imaging in Clinical Trials aims to educate and provide a hands-on text for those involved in clinical trials and either new to medical imaging and having to assimilate it into clinical trials or requiring to understand the key differences between clinical trial imaging and "routine" clinical imaging. It is targeted to those professionals involved in clinical trials at the clinical research site, pharmaceutical and medical device industries, and regulators. This is not the "how to image" book written for the radiologist or Radiological Technologist, but covers the critical aspects of clinical trial methodology that are important for these individuals to understand. This book addresses the ethics and radiation dosages of the different modalities, the end points commonly used for the different trial phases, the acquisition and analysis techniques, as well as the logistics management of medical imaging and the role of the central imaging lab or imaging core lab (ICL) which is now the standard requirement for clinical trials. Furthermore this text delves into the details of the major therapeutic areas where medical imaging plays a primary or secondary efficacy or safety end point.
