State of ACRIN : Extending our reach Mitchell Schnall MD, PhD Professor of Radiology University of Pennsylvania ACRIN Network Chair

ACRIN Scientific Strategy Develop and evaluate strategies for imaging surveillance of populations at high risk for cancer. Develop and validate imaging biomarkers to predict and monitor therapy response. Evaluate the effectiveness of imaging directed therapy on improving patient management and associated outcomes. This includes comparative effectiveness studies of existing imaging methods.

ACRIN Organizational Chart Organizational Changes ACRIN Organizational Chart Biostatistical & Data Management Center Chair Constantine Gatsonis, PhD Brown University Steering Committee Network Chair Mitchell Schnall, MD, PhD University of Pennsylvania Deputy Chairs Anat/Fxn Imaging Denise Aberle, MD UCLA Molecular Imaging Barry Siegel, MD Washington University ACRIN Foundation Jim Thrall, MD MGH NCI Paula Jacobs, PhD Cancer Imaging Program Leadership Council Mitchell Schnall, MD, PhD University of Pennsylvania Advisory Panel Daniel Sullivan, MD Duke University Data & Safety Monitoring Committee Daniel Sargent, PhD Mayo Clinic Network Administration Charles Apgar ACR Philadelphia Outcomes & Economics Core Laboratory William Black, MD Dartmouth Medical School Non NCI Disease Site Committees Disease Site Committees Scientific Support Committees Support Committees Patient Advocacy Peggy Anthony, RN, MHS Cardiovascular Pam Woodard, MD Washington University Breast Connie Lehman, MD University of Washington Informatics Daniel Rubin, MD Stanford University Patient Advocacy Peggy Anthony, RN, MHS Institutional Participants Committee Vice Chair Chris Comstock, MD Memorial Sloan Kettering Media / Publications and Dissemination Committee Vice Chair Laurie Fajardo, MD University of Iowa Quality Control Mitchell Schnall, MD, PhD University of Pennsylvania ACRIN PA Mitch Schnall, MD, PhD University of Pennsylvania Abdominal Terri Wong, MD Duke University Core Laboratory PET/Nuc Medicine Barry Siegel, MD Washington University MR/CT Mark Rosen, MD, PhD University of Pennsylvania Research Associates Wendy Smith, RT Rhode Island Hospital ACRIN Projects Mitch Schnall, MD, PhD University of Pennsylvania Head/Neck/CNS Dan Barboriak,, MD Duke University Gynecological Susanna Lee, MD Massachusetts General Hosp Special Populations Elizabeth Patterson, MD Head/Neck/CNS Dan Barboriak,, MD Duke University Neuroscience Greg Sorensen, MD Massachusetts General Hosp Ultrasound Working Group Barry Goldberg, MD Thomas Jefferson University Thoracic Caroline Chiles, MD Wake Forest University Experimental Imaging David Mankoff, MD University of Washington

Highlights: NLST publication 20% redcution in lung cancer mortality 7% redcution in all cause mortality

Highlights: Study Portfolio 11 open studies 2 Cardiovascular (RESCUE is opened) 9 Oncology (first multicenter optical imaging trial) Comparative effectiveness studies (RESCUE, 6690) 5 concepts in development E2410 trial in collaboration with ECOG Collaboration with QIBA Diffusion MRI in ISPY 2 DECAMP: impact of biomarkers in risk assessment and diagnostics related to lung cancer screening

Highlight: CQIE Goal: Qualify 59 cancer center in quantitative MRI, CT and PET imaging Accomplishments 52 sites fully qualified CT:57 PET: 54 MR: 54

Mid Term Review “Evaluation Committee members identified the Network as an invaluable national resource worthy of continued support” Screening program rated as exceptional Biomarkers program challenges acknowledged Smaller early phase studies Focus on compelling clinical problems (practice changing) Reduce trial complexity

Cooperative Group Reorganization Group Consolidation: no more than 4 adult groups Formation of a “Network” Harmonization of processes Trans network collaboration Network wide prioritization

Implications for ACRIN ACRIN would not be able to compete on its own for membership in the cooperative group network Opportunity for developing a formal structure for core support of the cooperative group network

ECOG-ACRIN Alliance “The groups plan to form an alliance that combines their complementary strengths” “The new organization will include three areas of research emphasis: early detection and diagnosis of cancer; biomarker-driven Phase II and Phase III therapeutic studies for multiple cancer types and stages; and genetic, molecular and imaging marker research to predict and monitor treatment response.”

Progress Name Program Structure Collaborative CCOP Research Base grant submission Joint trial (s) Developing Membership model Operational model Governance structure ECOG ACRIN

Overall Impact on ACRIN New Group ACRIN Oncology ECOG ACRIN Neuro- Sciences ACRIN Cardiology

EISC LAB SCI DT SX CER OTHER Underserved ECOG –ACRIN Cooperative Group, Inc. BOM OPS Scientific Steering Committee Biostats DM Cancer Control and Outcomes Biomarker Science Hamilton/Flaherty/Mankoff Therapeutics Sparano/ACRIN ECOG ACRIN PT CENTERED OUTCM/SURVIV Wagner/Black Early DETEC/DX/ PREVENTION Khuri/Schnall EISC DOC LAB SCI DT SX CER OTHER Underserved Outcomes Prev Det/Dx

Process Initial Presentation to group chairs: Nov 2010 Meeting with Chairs: Jan, March, April, May 2011 Vetting proposal/progress IOM/ASCO workshop (March 21, 2011) AACR (April 5th, 2011) ASCO, 2011 Developing FOA Aug 2011: internal NCI review Nov 2011: BSA Concept review July 2012: FOA released Nov 2012: Applications due Feb 2013: Review Roll out new awards in 2014

Hopes\Challenges for the Alliance: The ACRIN Perspective Strengthen cancer biology expertise contributing to imaging trial development More effective integration with therapeutic development Better access to trials with novel targeted therapeutics Better accrual to imaging biomarker studies Integrative approach to diagnostics Engagement of the cooperative group structure in studying the entire cancer care path Maintaining a scientific focus in early detection/diagnostics Adapting to the membership structure of the cooperative group network Maintaining the clinical trial infrastructure in the academic and practice community Continuing to be nimble enough to aggressively pursue opportunity

Seize the Day! Opportunity to develop the new model for cooperative group science Innovative science driven research Multimodality diagnostics Set the imaging agenda