This article is the second in a series of three providing a background and primer to radiologists and imaging professionals interested in clinical trials. It offers background on regulatory approval and on the use of surrogate endpoints and imaging biomarkers, as well as touching on the administration of medical imaging in clinical trials.
Over the past two decades, imaging has undergone revolutionary and evolutionary changes in both the clinical and nonclinical spheres. Part of this evolution has been the acceptance of imaging as an endpoint or marker for evaluation of the efficacy of therapy in clinical trials. As a result, new doors have opened for the involvement of radiologists