Report of Task Force II: Best Practices in the Use of Medical Imaging Techniques in Clinical Trials

There are few explicit guidelines governing how independent imaging core laboratories should operate or manage the procedures they use to support clinical trials of investigational new drugs. This task force was charged with harmonizing, and in some cases standardizing, the operating procedures that are used to analyze images by central laboratories. A group of about twenty-five imaging professionals worked to produce consensus on exactly what constituted good imaging practices by imaging core laboratories. The task force held bimonthly teleconferences, participated in three face-to-face meetings, and often split itself into smaller subgroups to address specific topics. The task force found that a variety of imaging operation and analysis approaches are common across most medical imaging techniques and therapeutic areas. Many seem to meet minimum threshold criteria for classification as good imaging practices, as defined by their ability to deliver reproducible, truly independent, and unbiased assessments that characterize the impact of drugs on the state of disease. This report describes some of the procedures that seem essential for using medical imaging techniques to support new drug applications.