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Todays Clinical Trials. Tomorrow’s Cures.

Todays Clinical Trials. Tomorrow’s Cures. Robert L. Comis, MD. National Coalition for Cancer Research “Cancer 101” Congressional Briefing 09/10/14. National Clinical Trials Network. Improvements: Shorter trial development timelines Central Institutional Review Board

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Todays Clinical Trials. Tomorrow’s Cures.

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  1. Todays Clinical Trials. Tomorrow’s Cures. Robert L. Comis, MD National Coalition for Cancer Research “Cancer 101” Congressional Briefing 09/10/14

  2. National Clinical Trials Network Improvements: Shorter trial development timelines Central Institutional Review Board Clinical trial and biorepository management software Closer collaboration among research groups

  3. National Clinical Trials Network Accomplishments: • Restructuring of cooperative groups has dramatically consolidated operations and should result in increased efficiency • Speed of trial activations has increased • Per case payments for some sites treating patients has increased Challenges: • Trials are much more complex and costly in era of personalized medicine, requiring more operational support • Budget reductions

  4. A Decade of Flat/Decreasing Funding

  5. NCI Funding 2000-2011 Deflated Using BRDPI BRDPI= Biomedical Research and Development Price Index 

  6. Budget History for Components of NCI Clinical Trials Network 8

  7. 5-Year Annual Funding Request forNCI Clinical Trials Network 9 * The 5-Year Total Cost Funding Request for FY2014 to FY2018 for the NCTN is $891,221,675

  8. NCI Award Budgets for Current Grant Cycle

  9. NCTN Budget Comparison

  10. Major Impact of Decrease in Operations Offices and Biostatistics and Data Management Centers Loss of experienced FTEs • 11.14 in Ops • 8.9 in BDMC Reduced support for scientific programs and their leadership $1M cut for laboratories 72% cut ($500k) in Institutional support

  11. Current NCTN Budget Situation Flat funding for a decade Increased trial expenses, particularly for those using molecular markers to select treatment Increased funding to network sites Decreased network capacity Lack of funding to support transition to decreased capacity

  12. Changing Trials Portfolio 2009 Accrual Distribution: Phase 3: 83.4% Phase 2: 15.1% Phase 1/Pilot: 1.5% 2014 Accrual Distribution: Phase 3: 30-45% Phase 2: 45-60% Phase 1/Pilot: ~1-2% • Few large phase III trials • Few adjuvant studies Require more operational support • More rare tumor trials • Molecular screening trials

  13. Decreased Accrual Capacity

  14. Fewer Trials/Fewer Patient Opportunities Hold on NCI review of any studies with projected accrual >1000 If hold is lifted for a particular trial, it undergoes a second round of NCI budgetary review Hold on involvement of international sites in new trials

  15. Final Points The NCI National Clinical Trials Network is an essential component of publicly-funded cancer research Current NCI budget constraints and holds on important types of cancer research are more serious than ever seen in the past Inadequate federal funding for cancer clinical research is particularly harmful and threatens the viability of ongoing work in the network

  16. Questions?

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