1. Clinical Trials Design, Development, and Outreach Working Group Richard L. Wahl, M.D. & John Buatti, M.D.

2. Conference Call Participants Richard L. Wahl, M.D. (chair) John Buatti, M.D. (co-chair, incoming chair), Brenda Kurland, Ph.D (incoming co-chair), James M. Mountz, Daniel Rubin, Christopher Ryan, Edward Eikman, Elizabeth Gerstner, Frank S. Lieberman, Ella Jones, Edward Graves, Andrew Quon, Hyunsuk Shim, Hannah Linden, Pushpa Tandon, Robert Nordstrom, Hao Wang, Larry Clarke,

3. Overall Goals Identify challenges and opportunities in clinical cancer imaging trial design and development, notably trials using quantitative imaging; Identify challenges and opportunities in clinical cancer imaging trial design and development, notably trials using quantitative imaging; Identify and test potential best practices for clinical trial design, analysis and reporting; Identify and test potential best practices for clinical trial design, analysis and reporting; Through collaborations with the other QIN working groups, facilitate introduction of QIN developed methods into clinical imaging trials; Through collaborations with the other QIN working groups, facilitate introduction of QIN developed methods into clinical imaging trials;

4. CTDDWG Goals: 2 Disseminate best clinical trial design and development methods through publications and guidelines; Disseminate best clinical trial design and development methods through publications and guidelines; Facilitate interactions with cooperative groups and other organizations interested in quantitative imaging by direct and continued engagement/cross-membership including introduction of quantitative imaging network methods into multicenter clinical trials and Facilitate interactions with cooperative groups and other organizations interested in quantitative imaging by direct and continued engagement/cross-membership including introduction of quantitative imaging network methods into multicenter clinical trials and Help export relevant and mature QIN methods to clinical practice settings as appropriate. Help export relevant and mature QIN methods to clinical practice settings as appropriate.

5. CTDDWG Goals: 2

6. Multi QIN Site Participation in QIBA-Funded Trial of Precision

7. Outreach QIN members have also worked to initiate small clinical trials including QIN sites, an example being a partly-intra QIN trial with FLT PET in brain tumor therapy assessment with a new treatment agent, this in an outreach effort with the Adult Brain Tumor Consortium. QIN related methods are also being considered in a large prospective trial of breast cancer neo-adjuvant therapy being developed with ACRIN-ECOG. The QIN CTDDWG has established formal liaison representation on the Biomarkers and Experimental Imaging committee of ACRIN-ECOG to facilitate interactions with ACRIN and through ACRIN with other NCI Cancer Therapy Consortia.

8. Summary: CTDDWG should become the CTDDOWG CTDDWG should become the CTDDOWG Several projects/MS ongoing/completed Several projects/MS ongoing/completed Considerable outreach among QIN sites and across organizations/nations Considerable outreach among QIN sites and across organizations/nations Formal input of QIN methods into new trials Formal input of QIN methods into new trials More formal engagement of QIN sites with cooperative imaging groups More formal engagement of QIN sites with cooperative imaging groups Focus for next year includes optimizing accrual & defining/exporting best quantitation practices Focus for next year includes optimizing accrual & defining/exporting best quantitation practices