There is increasing interest in using imaging methods as biomarkers as primary or secondary endpoints in clinical trials, especially therapeutic drug trials. There is particular interest in testing molecular imaging techniques as predictive or response biomarkers. A variety of academic, commercial, and government groups are addressing one or more aspects of the evaluation and validation of imaging methods as biomarkers for clinical research, and communication among these groups is often minimal or non-existent.

To promote an exchange of information, to assist all of these individual groups in sharpening the focus of their own goals and missions, and to reduce duplication of effort, the RSNA convened an Imaging Biomarkers Roundtable in Oak Brook, Illinois on April 3-4, 2008. Twenty-two groups, including 2 European groups, reported on their current and planned activities.

A list of important unsolved problems or areas requiring increased attention was identified, such as the need for improved phantoms, standardized image acquisition protocols, lexicons, publicly-available image archives, reduced regulatory hurdles, and more money for validation trials. A matrix listing all the various groups and their particular activities in evaluating or validating imaging biomarkers is being developed based on information shared at the Roundtable.

Future opportunities for continued communication and coordination of activities were requested by the participants.