PLENARY SESSION
Fall Group Meeting
Miami, FL
November 13, 2010
CALGB November 2010 Plenary Session
Introduction: Acknowledgements and Announcements
Monica Bertagnolli, MD
American College of Surgeons Oncology Group
Heidi Nelson, MD
North Central Cancer Treatment Group
Jan Buckner, 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
NCI Sponsored Cancer Cooperative Groups
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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)
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)
Anatomy of a Cooperative Group
As defined by the NCI, a cooperative group is created
by one or more federal grants that support:
Scientific Committees
Operational Infrastructure
disease committees
modality committees
administration
protocol office
data management center
grants administration
biorepository
COOPERATIVE GROUPS
Multidisciplinary Disease
Site Committees
Funding
Statistical
Offices
Data
Analysis
Publication
Concurrent
Peer Review of
Front Office
New
Performance
Metrics
Propose Trial Concepts
Prioritization
and Selection
via
Peer Review
NCI Support
Local
IRB
NCI
CIRB
High Priority Clinical Trial Protocols
Consolidated
with Full Funding from NCI
FDA
Patient enrollment at any trial site
certified to participate in a
National Trials Network
Data
Funding
Back Office
Peer Review
Operations
Of Back
And Data
Office
Management
Operations
New
Functions Performance
Metrics
A cooperative group is much more than
just its NCI-funded infrastructure
Members treating
patients
Members engaged
in translational
science
Time & Energy
Ideas
Resources
Member Institutions directly and
indirectly supporting group
research
Cooperative Group Funding Sources, 2010
Philanthropy
Institutional
Accrual Support
Federal Grants
Pro-Bono
Investigator Time
Industry
CTSU
CCOP Accrual Support
J. Hautala, CTAC Sept 21, 2010
CALGB Mission Statement
The purpose of the CALGB is to conduct
clinical studies that
lead to the prevention of cancer,
identify cures for cancer, or
improve the well being of patients
living with cancer.
Current Environment: Challenges
 Demand for evidence-based care

Balancing treatment benefits and risks
 Personalized medicine

Smaller study populations, need for large consortium
 Targeted therapeutics

Earlier biological endpoints, including imaging
 Explosion of molecular data

Useless without clinical correlation
 Heavy regulatory burden

Highly inefficient study approval & activation process
 Insufficient funding

Low per case funding mandates institutional support
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
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.”
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:
 Short term:
Regularly scheduled joint conference calls and
other planning meetings for the scientific
committees

Proposals for shared protocols or other scientific
activities
 Long term:
Single scientific agenda and consolidated
infrastructure spanning all three groups
Guiding principles
 Best science faster
 Members actively involved in the
development process for a unified
scientific agenda