SNM Molecular Imaging Summit Introduces Clinical Trials Network

More than 150 experts from molecular imaging, regulatory agencies, and the pharmaceutical industry came together on February 8 and 9, immediately after the SNM Mid-Winter meeting in Clearwater, FL, to advance the use of imaging biomarkers in multicenter drug development trials. The intensive 2-d workshop was organized by the SNM Molecular Imaging Center of Excellence and the SNM Clinical Trials Network leadership. The objectives were to discuss the need for imaging biomarkers in the development of therapeutic pharmaceuticals, to examine the challenges of imaging in multicenter trials, and to discuss the path forward to successful biomarker imaging for large multicenter clinical trials. The summit was an opportunity to learn how SNM’s new Clinical Trials Network can facilitate faster and more costeffective drug and biologics development through improved integration and standardization of imaging biomarkers into Phase 1, 2, 3, and 4 therapeutic clinical trials. The workshop outlined details of clinical sites’ participation in the network and examined the critical need for imaging standardization and harmonization across clinical trial sites. Gustav von Schulthess, MD, kicked off the meeting with a keynote address highlighting the importance of choosing the appropriate imaging modality and biomarker to address the clinical question being evaluated in the therapeutic clinical trial. He also emphasized the need for standardization of imaging protocols between different imaging centers and different types of imaging equipment (different vendors or performance levels). The formal program for the meeting then continued with a series of presentations highlighting both the needs and challenges associated with incorporating imaging into clinical trials. Of particular interest were presentations by