1) recommend best (preclinical) practices for efficiently evaluating and developing agents in the...
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Cancer Clinical Trials Aimed at Decreasing
Toxicity
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1) recommend best (preclinical) practices for efficiently evaluating and developing agents in the CMCR pipeline for possible applications in cancer patients
2) iron out how to efficiently move the most promising agents into appropriate clinical trials
3) develop a summary "position paper" to be published
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• Minimize DELAY and CONFUSION
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• Quality of life (mid 1980’s)
• Fatigue (2000)
• Curcumin (2006)
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QOL and cancer in title 1980 = 2 = .05% of articles with cancer in title (cancer alone = 3966)QOL and cancer 2008 = 355 = 1.2% of articles with cancer in title (cancer alone = 29940)
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• June 30, 2006 IND submitted• August 4, 2006 IND approved• August 31, 2006 “complete clinical
hold”
• July 25, 2007 “proceed”• July 26, 2007 “hold”• August 16, 2007 “approved”
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Involved :• 9 FDA staff• 4 FDA divisions• 1 FDA Ombudsman• 1FDA Chief• 1 US Congresswoman• 1 US Senator• 8 University of Rochester people
And 57 separate contacts over the 412 days
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What is a CCOP Research Base?
An NCI-designated Cancer Center or Cooperative Group
Funded by a Peer- Reviewed Cooperative Agreement
Develop and Conduct Cancer Prevention and Control Clinical Trials
Supports Development of Cancer Prevention Science
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CCOP Research Bases: Cooperative Groups
▪ Children’s Oncology Group▪ Cancer and Leukemia Group B▪ Eastern Cooperative Oncology Group▪ North Central Cancer Treatment Group▪ Radiation Therapy Oncology Group▪ Southwest Oncology Group▪ National Surgical Adjuvant Breast &
Bowel Project▪ Gynecologic Oncology Group
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CCOP Research Bases: Cancer Centers
H. Lee Moffitt Cancer Center M.D. Anderson Cancer Center University of Rochester Cancer Center
Wake Forest University Cancer Center
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Central Illinois CCOP Gulf Coast MBCCOP North Shore University Hospital CCOPColumbia River CCOP Hawaii MBCCOP Northwest CCOP
Columbus CCOP Hematology-Oncology of CNY CCOPSoutheast Cancer Control Consortium
Dayton Clinical Oncology Program Kalamazoo CCOPUniversity of Illinois at Chicago MBCCOP
Evanston CCOP Kansas City CCOP Upstate Carolina CCOP
Grand Rapids CCOPMarshfield Clinic Research Foundation CCOP
Virginia Mason Research Center CCOP
Greenville CCOP Metro-Minnesota CCOP Wichita CCOPNevada Cancer Research Foundation CCOP
CCOPs
URCC
UNIVERSITY OF ROCHESTER CANCER CENTERCOMMUNITY CLINICAL ONCOLOGY RESEARCH BASEMAP OF AFFILIATES (2009)
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0
2
4
6
8
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2000 2001 2002 2003 2004 2005 2006 2007 2008Cancer Control Accruals(CCOPs and MBCCOPs)
Tho
usan
ds
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• What is appropriate FDA review expertise for this research?
• Where is it found administratively?
• How can mutually beneficial collaborative relationships be promoted?
• Is there a way to have this all be more timely?
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Gary Morrow, PhD, MS URCC CCOP Research Base 20
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CCOPs & [MB-CCOPs]
Accrual to Protocols
Data Management
Quality Control
Research Bases
(Groups/Centers)
Develop Protocols
Data Management and Analysis
Quality Assurance
Members and Affiliates
Accrual to Prevention and Control Protocols
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March 2007
(50)(13)
(395)