Cancer Clinical Research

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Cancer Clinical Research Community Collaborations
Leslie G. Ford, M.D. Associate Director for
Clinical Research Division of Cancer
Prevention November 5, 2002
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Community Collaborations

• Physician/Researcher Community
• Participant Community

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Cancer Clinical Research in the Community
27 Years of Progress
COP
CHOP
CCOP
1975
1981
1983
2002
COP Clinical Oncology Program CHOP Community
Hospital Oncology Program CCOP Community
Clinical Oncology Program
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CCOP Mission

• Bring the advantages of state-of-the-art cancer
  treatment, prevention, and control research to
  individuals in their own communities by
• Involving community physicians and their patients
  in NCI-approved clinical trials
• Involving primary health care providers in
  research process

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What is a CCOP?

• Consortium of community hospitals and physicians
• Funded by peer-reviewed cooperative agreement
• Participate in NCI-approved cancer treatment,
  prevention, and control clinical trials

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What is a Research Base?

• A research base is an entity that assumes a broad
  range of responsibilities and functions for the
  support of clinical trials conducted under its
  name.
• The research base supports the investigator in
  developing, organizing, implementing, and
  analyzing clinical trials.

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Funded Programs

• 50 CCOPs (30 States)
• 11 MBCCOPs (8 States, DC Puerto Rico)
• 12 Research Bases across the U.S.

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Impact of the CCOP

• Since 1983
• 92,500 patients on treatment clinical trials
• 50,200 patients and individuals at risk for
  cancer on prevention and control clinical trials
• 4,035 physicians
• 405 hospitals

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CCOP Accomplishments

• Successful involvement of community oncologists
  as equal partners in research process
• Enhanced adoption of state-of-the-art care
• Establishment of research network that extends
  beyond medical oncologists

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CCOP Accomplishments

• Access to clinical trials for minorities and
  their physicians (MBCCOP)
• Extension of scientific purview of research bases
  to include cancer prevention and control
• Successful mechanism for implementing landmark
  prevention trials

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Large Prevention Trials

• Breast Cancer Prevention Trial
• N 13,388 Completed 1998
• Prostate Cancer Prevention Trial
• N 18,882 Completion May 2004
• Selenium and Vitamin E Cancer Prostate Cancer
  Prevention Trial
• N 32,400 Current accrual 16,116

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Large Prevention Trials

• Study of Tamoxifen and Raloxifene (STAR)
• N 22,000
• Current accrual 14,568

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P-2 STAR Sites in U.S., Canada Puerto Rico
?
P1 P2 site New P2 site
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Community Collaboration

• STAR Participant Advisory Board
• Group of 16 STAR participants
• Serves in an advisory capacity
• Provide feedback on all aspects of trial
• Study design
• Communication strategies
• Recruitment and adherence

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Participant Advisory Board
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Community Advocate Collaborations

• Involvement in NCIs
• Concept Evaluation Panels
• State of the Science Meetings
• Involvement in Cooperative Groups
• Data Safety Monitoring Committees
• Scientific Disease Committees
• Coalitions Patient Advisory Board

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Community Collaboration

• Community advocates are woven through the entire
  fabric of the NCIs Clinical Trials Program