PLENARY SESSION Fall Group Meeting Miami, FL November 13, 2010

CALGB November 2010 Plenary Session Introduction: Acknowledgements and Announcements Monica Bertagnolli, MD North Central Cancer Treatment Group Jan Buckner, MD American College of Surgeons Oncology Group Heidi Nelson, MD Operational Integration: The CALGB, NCCTG, ACOSOG Statistics and Data Center Dan Sargent, PhD Collaboration Between CALGB, NCCTG and ACOSOG Monica Bertagnolli, MD

CALGB-NCCTG-ACOSOG November 2010 Monica Bertagnolli, MD CALGB Group Chair

Multimodality: Cancer and Acute Leukemia Group B (CALGB) Eastern Cooperative Oncology Group (ECOG) North Central Cancer Treatment Group (NCCTG) Southwest Oncology Group (SWOG) NCI of Canada – Clinical Trials Group (NCIC-CTG) NCI Sponsored Cancer Cooperative Groups Specialty: American College of Surgeons Oncology Group (ACOSOG) National Surgical Adjuvant Breast & Bowel Project (NSABP) Gynecologic Oncology Group (GOG) Radiation Therapy Oncology Group (RTOG) Children’s Oncology Group (COG)

Operational Infrastructure administration protocol office data management center grants administration biorepository Anatomy of a Cooperative Group Scientific Committees disease committees modality committees As defined by the NCI, a cooperative group is created by one or more federal grants that support:

Multidisciplinary Disease Site Committees Statistical Offices Data Analysis Publication Concurrent Peer Review of Front Office Propose Trial Concepts Prioritization and Selection via Peer Review High Priority Clinical Trial Protocols with Full Funding from NCI COOPERATIVE GROUPS New Performance Metrics Funding Peer Review Of Back Office Operations Consolidated Back Office Operations And Data Management Functions Funding New Performance Metrics FDA NCI CIRB Local IRB Data Patient enrollment at any trial site certified to participate in a National Trials Network NCI Support

A cooperative group is much more than just its NCI-funded infrastructure Members treating patients Members engaged in translational science Member Institutions directly and indirectly supporting group research Time & Energy Ideas Resources

Cooperative Group Funding Sources, 2010 Federal Grants CCOP Accrual Support CTSU Industry Philanthropy Pro-Bono Investigator Time Institutional Accrual Support J. Hautala, CTAC Sept 21, 2010

CALGB Mission Statement The purpose of the CALGB is to conduct clinical studies that improve the well being of patients living with cancer. lead to the prevention of cancer, identify cures for cancer, or

 Personalized medicine Smaller study populations, need for large consortium  Heavy regulatory burden Highly inefficient study approval & activation process  Targeted therapeutics Earlier biological endpoints, including imaging  Demand for evidence-based care Balancing treatment benefits and risks Current Environment: Challenges  Explosion of molecular data Useless without clinical correlation  Insufficient funding Low per case funding mandates institutional support

The report emphasizes the need to maintain a robust, standing cancer clinical trials network by “ preserving the historical strengths of the Cooperative Group Program while improving components that are not working well.” Institute of Medicine Committee on Improving Cancer Clinical Trials and the NCI Cooperative Group Program “…the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care….” IOM Report = a roadmap for positive change

Response to IOM Report Actively seek collaborations that maximize our ability to achieve our mission June, 2010: Initiate transition to Consolidated Statistics and Data Management Center in collaboration with NCCTG and ACOSOG November, 2010: Explore additional opportunities for mutual benefit based upon cooperation between members of ACOSOG, NCCTG and CALGB

ACOSOG Mission Statement  ACOSOG is dedicated to improving the care of the surgical oncology patient Increase response and cure rates Reduce morbidities and disabilities Better understand the biologic basis of early-stage disease and its treatment

NCCTG Mission Statement To improve the duration and quality of life of cancer patients and survivors by:  Conducting high quality multidisciplinary cancer treatment and cancer control trials in the community setting  Improving our understanding of cancer biology and the biological consequences of treatment, and  Improving quality, efficiency, and value of clinical trial conduct and delivery of cancer care in the community

What kinds of studies should we conduct? High impact, practice-changing Even if this means: More difficulty Fewer trials overall Studies that others cannot do Not attractive to industry Special populations Multidisciplinary

Overarching themes: We won’t achieve our scientific goals unless our studies: Activate quickly Accrue rapidly Run smoothly BEST SCIENCE: Collaborate as widely as necessary to achieve this

COLLABORATION BETWEEN CALGB, ACOSOG, AND NCCTG Monica Bertagnolli, MD CALGB Group Chair

Asking the members…. Who are we? Begin discussion with plenary sessions at each group What are our priorities? What important goals can we accomplish together that we could not achieve alone?

Immediate goals: Operations  Complete the transition phase of the integrated Statistics and Data Management Center  Joint application for U24 funding to support biorepositories: spring, 2011 Single “virtual” bank Harmonized processes Avoid duplication of services

Scientific goals:  Long term: Single scientific agenda and consolidated infrastructure spanning all three groups  Short term: Regularly scheduled joint conference calls and other planning meetings for the scientific committees Proposals for shared protocols or other scientific activities

Guiding principles  Members actively involved in the development process for a unified scientific agenda  Best science faster