Cancer Clinical Trials Aimed at Decreasing Toxicity

1. Cancer Clinical Trials Aimed at Decreasing Toxicity

2. The key goals of this workshop are to: 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

3. “The Patron Saint of Clinical Trials”

4. Key to clinical trials: • Minimize DELAY and CONFUSION

6. Three (hopefully idiosyncratic) stories of reduced efficiency that led to increased delay and confusion • Quality of life (mid 1980’s) • Fatigue (2000) • Curcumin  (2006)

7. Number of Articles in Pub Med with ‘Cancer’ and ‘Quality of Life’ in Titles 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)

8. Number of Articles in Pub Med with ‘Cancer’ and ‘Fatigue’ in title by Year

9. Policy Statement

10. Better later than never?

11. The Curcumin Soap Opera:more delay and confusion • 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. The Rest of the Story:the cast of players 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. Community Clinical Oncology Program:appropriate clinical trials 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. Community Clinical Oncology Program 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. Community Clinical Oncology Program 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. UNIVERSITY OF ROCHESTER CANCER CENTER COMMUNITY CLINICAL ONCOLOGY RESEARCH BASE MAP OF AFFILIATES (2009) URCC CCOPs

17. Community Clinical Oncology Program Accruals

18. New, Improved CCOP Protocol review

19. How to iron out how to efficiently move the most promising agents into appropriate clinical trials: • 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

21. CCOP Organizational Relationships • Research Bases • (Groups/Centers) • Develop Protocols • Data Management and Analysis • Quality Assurance • CCOPs & [MB-CCOPs] • Accrual to Protocols • Data Management • Quality Control • Members and Affiliates • Accrual to Prevention and Control Protocols

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