Childrens Oncology Group National International Infrastructure for Pediatric Cancer Clinical And Tra

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Childrens Oncology Group National /
International Infrastructure for Pediatric Cancer
Clinical And Translational Research

• Maura OLeary, MD
• Administrative Officer
• Childrens Oncology Group
• June 28, 2007

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Childrens Oncology Group

• Unification of 4 North American based pediatric
  clinical trials groups
• Childrens Cancer Group
• Pediatric Oncology Group
• National Wilms Tumor Study Group
• Intergroup Rhabdomyosarcoma Study Group

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• Background
• Impact of Cooperative Group Science on Clinical
  Outcomes
• Description/Membership
• Administrative Organization/Finances
• Scientific Organization
• Centralized Reference Labs
• Specimen/Tissue Banking
• Study Development
• Limited Consortia
• Advice re. clinical trial network development

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Background

• Collaborative, multi-center research has
  transformed pediatric cancer from a nearly
  universally fatal disease to one that is curable
  in gt 75 of patients
• This remarkable, shared achievement has resulted
  from efforts of laboratory scientists and
  clinical investigators in the cooperative
  clinical trials groups

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The National Childhood Cancer Mortality Rate and
the Pediatric Cooperative Groups
Annual USA Cancer Mortality Rate Children lt15
Years
Mortality per 100,000, Age- Adjusted
COG
1950
1960
1970
1980
1990
2000
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Mission

• To cure and prevent childhood and adolescent
  cancer through scientific discovery and
  compassionate care

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Mission

• Design and conduct clinical trials to define
  optimal treatments
• Conduct laboratory investigations to translate
  into more effective and less toxic treatments
  (genomic approaches)
• Identify the causes of childhood cancer
• Conduct research to improve the quality of life
  and quality of survivorship
• Build partnerships which will help fulfill the
  mission of the COG globally

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Critical Contributions to Success

• Empiric multi-agent chemotherapy
• Improved classification and staging of pediatric
  malignancies
• Clinical/biologic risk-factors
• Adjuvant and neo-adjuvant chemotherapy
  contributions to multi-modality treatment
• Rare Tumors
• Improvements in supportive care

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Survival Comparison COG ALL Study Series

Estimated Survival Percentage
Years From Study Entry
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COG Accrual
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Childrens Oncology Group

• Largest childhood cancer research organization in
  the world
• Encompasses gt 200 pediatric cancer programs in
  North America, Australia, New Zealand,
  Switzerland, and the Netherlands
• Multidisciplinary research enterprise
• Uniquely able to establish a national childhood
  cancer registry - CCRN

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Membership

• Institutional Membership
• Inclusive
• Meet criteria (AAP/ASPHO) for pediatric oncology
  programs (COMPETENCE)
• 12 new patient registrations, 6 therapeutic study
  enrollments, 2 non-therapeutic study enrollments
  (COMMITMENT)
• Performance study eligibility, data quality,
  regulatory, IRB (COMPLIANCE)
• Individual Full Associate-Approved by
  discipline
• International Associate

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Financial Support

• NCI supported (CTEP, Division of Cancer Treatment
  and Diagnosis)
• Cooperative Agreement (U-10)- Involvement of
  Program staff (Terms of Grant Award)
• Group Chairs Grant 29 Million
• Statistical and Data Center 5 Million
• CCOP Grant
• Phase I Consortium Grant 1.5 Million
• Investigator initiated grants for correlative
  laboratory investigations
• Pharmaceutical company support (purchased
  services)
• Direct and Indirect (CRADA)
• Philanthropy (NCCF)5-10 Million

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Financial (cont.)- Funds Disbursement

• Group Chairs Office- 3.4
• Administrative, Regulatory Affairs
• Discretionary funds for Translational Research
  and Young Investigator Awards
• International Outreach, startup funds - new
  members
• Group Operations Center- 11.7
• Administrative, Study Development, Quality
  Assurance and Audit

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Financial (cont.)- Funds Disbursement

• Institutional Support- 61.2
• Per case reimbursement (rare supplements)
• 2,000 therapeutic
• 500 non-therapeutic
• Salary support-PI
• Salary support-Study Chairs, Committee Chairs,
  and Lab Directors
• Laboratory Support- 15.3
• Travel/Biannual Group Meetings/Special Meetings-
  8.4

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National Childhood Cancer Foundation

• Recognized/approved by the federal government as
  qualified to receive and manage federal awards
  for research and education, including grants,
  contracts and cooperative agreements
• Legal and fiscal grantee organization for the
  COG submit applications, negotiate contracts,
  accept awards, manage revenues and expenditures
  for all COG Group-wide scientific and educational
  activities on behalf of the COG Chair

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Foundation (cont.)

• Annually negotiates and manages over 200 master
  agreement subcontracts and with COG member
  institutions, to convey funds for patient
  accruals, study committee, centralized reference
  lab, review center and other leadership
  responsibilities accepted by specific COG
  investigators
• Provides administrative support services to the
  COG (i.e. space, insurance, IT, Human Resources)
  Responsible to funding agencies oversight of COG
  compliance with all applicable Federal regulations

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Childrens Oncology Group Leadership
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Group Operations Center
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COG Scientific Organization
Scientific Advisory Committee
Scientific Council
Group Chair
Biopath. Center
Resource Labs
Review Centers
Chairs Office
Operations Center
Statistics Data Center
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