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News from the Frontline

News from the Frontline

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News from the Frontline

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  1. News from the Frontline Leslie G. Ford, M.D. Associate Director for Clinical Research Division of Cancer Prevention NCI/NIH/DHHS March 18, 2003

  2. Dr. Elias ZerhouniNIH Director

  3. NIH Roadmap: Themes • New Pathways to Discovery • Re-engineering ClinicalResearch Enterprise • Research Teams of Future

  4. Dr. Andrew von Eschenbach NCI Director

  5. NCI’s Strategic Vision Discovery Development Delivery Discovery of relevant mechanisms Development of interventions for better prevention, detection, diagnosis, and treatment Delivery broadly

  6. DCP Drug Development Phase III Trials CCOPs, Cooperative Groups Safety/Preliminary Efficacy Phase I/II Trials Clinical Program Preclinical Program Biologic Rationale/Molecular Targets/Preclinical Efficacy

  7. Phase I Trials • 13 approved/active trials • Funded through contracts

  8. Phase II Trials • 54 approved/active trials • Contracts………………………….. 28 • Grants/Coop Agreement……………20 • Other support……………………… 5 • NCI Intramural………………………1

  9. Agent Decision Meetings • Review agents in prevention trials • Make decisions to continue investment • Review promising agents or molecular targets • Make decisions to proceed with further development • Prioritize agents

  10. Agent Decision Meetings • April 6, 2001 (DFMO & Iressa) • July 23, 2001 (Bowman Birk Inhibitor) • April 23, 2002 (4HPR, retinoids, PPARs) • September 26, 2002 (oltipraz & glutathione s-transferase modulation)

  11. Interactions with FDA • 56 INDs in 6 FDA Divisions • Monthly FDA/DCP interdivisional meetings • scientific issues (endpoints) • safety issues (toxicity ) • consistency

  12. Green teaLycopeneResveritrolTargretin Planned and New INDs (32 active INDs)

  13. Community Clinical Oncology Program (CCOP) 90 approved/active Phase I, II, III Cancer Prevention and Control Trials

  14. CCOP Cancer Prevention Trials22 active/approved • Prostate • Lung • Bladder • Breast and GYN • Colon • Head and Neck

  15. Community Clinical Oncology Program Accrual to large Phase III Cancer Prevention Trials • SELECT 20,000 (62%) • STAR 15,500 (82%)

  16. RFP for Early Phase Clinical Trials • Replace master agreement • Establish multi-institutional infra-structure • Conduct Phase I and II cancer prevention clinical trials.

  17. Common Data Elements • NCI effort to standardize data collection. • Expedite protocol development and review • Common definitions in case report forms. • Facilitate sharing of data across DCP, NCI, and research sites

  18. “He is a better physician that keeps diseases off us, than he that cures them being on us; prevention is so much better than healing because it saves the labour of being sick.”Thomas Adams, 1618