Table 1.

Comparison of routine clinical imaging with imaging in the setting of a clinical trial

Routine clinical imaging	Imaging in clinical trial
Assessment of response made using standard criteria, but often interpreted together with clinical and laboratory findings	Assessment of response made using strict objective criteria as set out in study protocol
Imaging performed when clinically indicated	Imaging performed as per study protocol, which is commonly more frequent than in clinical practice
Imaging studies are archived on picture archiving systems (PACS) in a clinical department according to hospital policy	In addition to local archiving, many clinical trial images will need to be exported to a single location for centralised radiological review
Imaging data are archived with patient identifiable information	Imaging data to be exported for analysis requires full anonymisation and should be identifiable only by a code
Imaging studies are reported as per clinical practice	Imaging studies are read using study criteria and clinical report forms have to be completed. In addition to reading by the site radiologist, centralised scans are often independently reviewed
Quantitative measurements not usually audited	Measurements are subject to an auditing process that may involve CROs