2. 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

4. Minimize DELAY and CONFUSION

6. Quality of life (mid 1980’s) Fatigue (2000) Curcumin (2006)

7. 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)

11. 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”

12. 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

13. 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

14. 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

15. 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

16. Central Illinois CCOPGulf Coast MBCCOPNorth Shore University Hospital CCOP Columbia River CCOPHawaii MBCCOPNorthwest CCOP Columbus CCOPHematology-Oncology of CNY CCOPSoutheast Cancer Control Consortium Dayton Clinical Oncology ProgramKalamazoo CCOPUniversity of Illinois at Chicago MBCCOP Evanston CCOPKansas City CCOPUpstate Carolina CCOP Grand Rapids CCOPMarshfield Clinic Research Foundation CCOPVirginia Mason Research Center CCOP Greenville CCOPMetro-Minnesota CCOPWichita CCOP Nevada Cancer Research Foundation CCOP CCOPs URCC UNIVERSITY OF ROCHESTER CANCER CENTER COMMUNITY CLINICAL ONCOLOGY RESEARCH BASE MAP OF AFFILIATES (2009)

19. 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?

20. Gary Morrow, PhD, MS URCC CCOP Research Base 20

21. 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

22. March 2007 (50) (13) (395)