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