PLENARY SESSION Fall Group Meeting Miami, FL November 13, 2010.
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PLENARY SESSION
Fall Group Meeting
Miami, FL
November 13, 2010
CALGB November 2010 Plenary Session
Introduction: Acknowledgements and AnnouncementsMonica Bertagnolli, MD
North Central Cancer Treatment GroupJan Buckner, MD
American College of Surgeons Oncology GroupHeidi 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 Infrastructureadministrationprotocol officedata management centergrants administration biorepository
Anatomy of a Cooperative Group
Scientific Committeesdisease committeesmodality 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
ConcurrentPeer Review of
Front Office
Propose Trial Concepts
Prioritizationand Selection
viaPeer Review
High Priority Clinical Trial Protocolswith Full Funding from NCI
COOPERATIVE GROUPS
New Performance
Metrics
Funding
Peer ReviewOf BackOffice
Operations
ConsolidatedBack OfficeOperationsAnd Data
ManagementFunctions
Funding
New Performance
Metrics
FDANCI
CIRB
LocalIRB
Data
Patient enrollment at any trial sitecertified to participate in aNational Trials Network
NC
I S
uppo
rt
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 SupportCTSU
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-changingEven if this means:
More difficulty
Fewer trials overall
Studies that others cannot doNot 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
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